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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
2
Product Code
EZX
Mesh, Surgical, Metal
2
Product Code
MIB
Elastomer, Silicone Block
2
Product Code
MIC
Implant, Muscle, Pectoralis
2
Product Code
BTX
Board, Arm (With Cover), Sterile
1
Product Code
FTL
Mesh, Surgical, Polymeric
2
Product Code
FTM
Mesh, Surgical
2
Product Code
FTN
Plastic Surgery And Accessories Kit
1
Product Code
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
3
Product Code
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
3
Product Code
FWP
Prosthesis, Chin, Internal
2
Product Code
FYI
Appliance, Facial Fracture, External
1
Product Code
FZD
Prosthesis, Ear, Internal
2
Product Code
FZE
Prosthesis, Nose, Internal
2
Product Code
FZF
Splint, Extremity, Inflatable, External
1
Product Code
GBI
Material, External Aesthetic Restoration, Used With Adhesive
1
Product Code
K
88
0329
FACTOR II PROSTHETIC SILICONE ELASTOMER
1
Cleared 510(K)
K
87
4279
AHH NATURAL BREAST FORM
1
Cleared 510(K)
K
87
2714
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
1
Cleared 510(K)
K
86
4785
AMOENA BREAST FORMS
1
Cleared 510(K)
K
86
4786
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
1
Cleared 510(K)
K
85
3822
AMOENA BREAST FORMS
1
Cleared 510(K)
K
85
1668
PROSTHESIS OR SURGICAL PADS
1
Cleared 510(K)
K
84
2765
SILIMED BREAST FORM
1
Cleared 510(K)
K
84
1559
CONFORMA
1
Cleared 510(K)
K
84
1171
TRILICON BREASE PROSTHESIS DIFFERENT
1
Cleared 510(K)
K
83
2151
PDM SILOXANE PROSTHETIC ORBIT
1
Cleared 510(K)
K
83
2153
PDM SILOXANE PROSTHETIC NOSE
1
Cleared 510(K)
K
83
2152
PDM SILOXANE PROSTHETIC EAR
1
Cleared 510(K)
K
83
1831
TRULIFE SILICONE BREAST FORM
1
Cleared 510(K)
K
81
3416
EXTERNAL BREAST PROSTHESIS
1
Cleared 510(K)
K
79
2372
IPOS BREAST PROSTHESIS
1
Cleared 510(K)
K
77
0359
IMPLANTING OF POLYACRYLIC FIBERS
1
Cleared 510(K)
GBJ
Prosthesis, Adhesive, External
1
Product Code
JCQ
Prosthesis, Esophagus
2
Product Code
KCZ
Prosthesis, Breast, External, Used With Adhesive
1
Product Code
KDA
Prosthesis, Ptfe/Carbon-Fiber
2
Product Code
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
2
Product Code
LZK
Implant, Malar
2
Product Code
MCA
Tape, Surgical, Internal
2
Product Code
MNF
Implant, Temporal
2
Product Code
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
1
Product Code
NOD
Board, Arm (With Cover), Non-Sterile
1
Product Code
NOJ
Prosthesis, Breast, External, No Adhesive
1
Product Code
NOK
Material, External Aesthetic Restoration, No Adhesive
1
Product Code
NWA
Prosthesis, Tracheal, Preformed/Molded
2
Product Code
NYT
Prosthesis, Tracheal, Expandable, Polymeric
2
Product Code
ODU
Facial Implant
2
Product Code
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OOD
Surgical Film
2
Product Code
OQL
Mesh, Surgical, Deployment Balloon
2
Product Code
ORQ
Mesh, Surgical, Deployer
2
Product Code
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
2
Product Code
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
2
Product Code
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
2
Product Code
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
2
Product Code
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
2
Product Code
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
2
Product Code
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
2
Product Code
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
2
Product Code
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
2
Product Code
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
2
Product Code
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
2
Product Code
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
2
Product Code
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
2
Product Code
OXL
Mesh, Surgical, Absorbable, Organ Support
2
Product Code
OXM
Mesh, Surgical, Absorbable, Fistula
2
Product Code
OXN
Mesh, Surgical, Collagen, Fistula
2
Product Code
PIJ
Collagen Surgical Mesh Containing Drugs
2
Product Code
PQN
Carbon Dioxide Gas Controlled Tissue Expander
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-d—prosthetic-devices
/
GBI
/
K770359
View Source
IMPLANTING OF POLYACRYLIC FIBERS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K770359
510(k) Type
Traditional
Applicant
ALLAN V. MARSE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/8/1977
Days to Decision
45 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
EZX
Mesh, Surgical, Metal
MIB
Elastomer, Silicone Block
MIC
Implant, Muscle, Pectoralis
BTX
Board, Arm (With Cover), Sterile
FTL
Mesh, Surgical, Polymeric
FTM
Mesh, Surgical
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
FYI
Appliance, Facial Fracture, External
FZD
Prosthesis, Ear, Internal
FZE
Prosthesis, Nose, Internal
FZF
Splint, Extremity, Inflatable, External
GBI
Material, External Aesthetic Restoration, Used With Adhesive
K
88
0329
FACTOR II PROSTHETIC SILICONE ELASTOMER
K
87
4279
AHH NATURAL BREAST FORM
K
87
2714
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
K
86
4785
AMOENA BREAST FORMS
K
86
4786
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K
85
3822
AMOENA BREAST FORMS
K
85
1668
PROSTHESIS OR SURGICAL PADS
K
84
2765
SILIMED BREAST FORM
K
84
1559
CONFORMA
K
84
1171
TRILICON BREASE PROSTHESIS DIFFERENT
K
83
2151
PDM SILOXANE PROSTHETIC ORBIT
K
83
2153
PDM SILOXANE PROSTHETIC NOSE
K
83
2152
PDM SILOXANE PROSTHETIC EAR
K
83
1831
TRULIFE SILICONE BREAST FORM
K
81
3416
EXTERNAL BREAST PROSTHESIS
K
79
2372
IPOS BREAST PROSTHESIS
K
77
0359
IMPLANTING OF POLYACRYLIC FIBERS
GBJ
Prosthesis, Adhesive, External
JCQ
Prosthesis, Esophagus
KCZ
Prosthesis, Breast, External, Used With Adhesive
KDA
Prosthesis, Ptfe/Carbon-Fiber
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZK
Implant, Malar
MCA
Tape, Surgical, Internal
MNF
Implant, Temporal
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOD
Board, Arm (With Cover), Non-Sterile
NOJ
Prosthesis, Breast, External, No Adhesive
NOK
Material, External Aesthetic Restoration, No Adhesive
NWA
Prosthesis, Tracheal, Preformed/Molded
NYT
Prosthesis, Tracheal, Expandable, Polymeric
ODU
Facial Implant
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
OOD
Surgical Film
OQL
Mesh, Surgical, Deployment Balloon
ORQ
Mesh, Surgical, Deployer
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXL
Mesh, Surgical, Absorbable, Organ Support
OXM
Mesh, Surgical, Absorbable, Fistula
OXN
Mesh, Surgical, Collagen, Fistula
PIJ
Collagen Surgical Mesh Containing Drugs
PQN
Carbon Dioxide Gas Controlled Tissue Expander
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-d—prosthetic-devices
/
GBI
/
K770359
View Source
IMPLANTING OF POLYACRYLIC FIBERS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K770359
510(k) Type
Traditional
Applicant
ALLAN V. MARSE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/8/1977
Days to Decision
45 days