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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
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
FPX
Strip, Adhesive, Closure, Skin
1
Product Code
K
97
0441
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
1
Cleared 510(K)
K
95
2947
DELPORE SKIN CLOSURE
1
Cleared 510(K)
K
95
2702
DERMA SEAL
1
Cleared 510(K)
K
94
6321
BIOSTRIP STERILE WOUND CLOSURE STRIP
1
Cleared 510(K)
K
93
1005
DUKAL SKIN CLOSURE STRIP
1
Cleared 510(K)
K
92
1775
SPYROFLEX WOUND CLOSURES
1
Cleared 510(K)
K
89
4802
AWC BUTTERFLY WOUND CLOSURES
1
Cleared 510(K)
K
89
4205
TECNOL SILK STRIP
1
Cleared 510(K)
K
87
4813
OMED WOUND CLOSURE STRIPS
1
Cleared 510(K)
K
84
0945
SKIN CLOSURE
1
Cleared 510(K)
K
84
2621
SUTURE STRIP
1
Cleared 510(K)
K
83
3258
SKIN TECH. SURGI-STRIPS
1
Cleared 510(K)
K
83
3083
DERMA STRIP-TM SKIN CLOSURES
1
Cleared 510(K)
K
83
1438
ELASTOPLAST
1
Cleared 510(K)
K
83
1439
ELASTOPLAST T.P.N.
1
Cleared 510(K)
K
82
1763
SHUR-STRIP APPLICATOR
1
Cleared 510(K)
K
80
2385
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
1
Cleared 510(K)
K
80
2384
CENTRAL VENOUS CATHETER DRESSING TRAY
1
Cleared 510(K)
K
80
1837
PLASTIC STRIP BANDAGES
1
Cleared 510(K)
K
80
1884
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
1
Cleared 510(K)
K
79
2725
FIXOMULL
1
Cleared 510(K)
K
79
2726
LEUKOFIX POROS
1
Cleared 510(K)
K
79
2667
LEUKOCLIP POROS
1
Cleared 510(K)
K
79
2136
HYPO-ALLERGENIC PLASTIC TAPE
1
Cleared 510(K)
K
79
2360
HANSAPOR STERILE
1
Cleared 510(K)
K
79
0140
SKIN CLOSURE TAPES STERILE
1
Cleared 510(K)
K
78
2003
BAND AID* ADHESIVE BANDAGES
1
Cleared 510(K)
K
78
1952
PAPER TAPE, HYPO ALLERGENIC
1
Cleared 510(K)
K
78
0565
SUTURELESS SKIN CLOSURE
1
Cleared 510(K)
K
77
2020
CLOTH ADHESIVE TAPE
1
Cleared 510(K)
K
77
1125
POLYURETHANE PROD. FOR I.V. NEEDLES
1
Cleared 510(K)
K
77
0533
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
1
Cleared 510(K)
K
77
0081
BAND-AID BRAND OF ADHESIVE BANDAGES
1
Cleared 510(K)
K
77
0339
BANDAGE, PLASTIC & SHEER
1
Cleared 510(K)
K
77
0180
SUB. OF DIACETONE ACRYLAMIDE
1
Cleared 510(K)
FPY
Sheet, Burn
1
Product Code
KGX
Tape And Bandage, Adhesive
1
Product Code
KMF
Bandage, Liquid
1
Product Code
LRS
I.V. Start Kit
2
Product Code
MCY
Wound Dressing Kit
2
Product Code
MHW
Dressing, Compression
1
Product Code
NEC
Bandage, Liquid, Skin Protectant
1
Product Code
OXQ
Dressing Change Tray
1
Product Code
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
1
Product Code
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 13 December 2024 at 11:05 pm
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FPX
/
K801837
View Source
PLASTIC STRIP BANDAGES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801837
510(k) Type
Traditional
Applicant
MARTIN'S MAINE EXCHANGE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/1980
Days to Decision
91 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
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
FPX
Strip, Adhesive, Closure, Skin
K
97
0441
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
K
95
2947
DELPORE SKIN CLOSURE
K
95
2702
DERMA SEAL
K
94
6321
BIOSTRIP STERILE WOUND CLOSURE STRIP
K
93
1005
DUKAL SKIN CLOSURE STRIP
K
92
1775
SPYROFLEX WOUND CLOSURES
K
89
4802
AWC BUTTERFLY WOUND CLOSURES
K
89
4205
TECNOL SILK STRIP
K
87
4813
OMED WOUND CLOSURE STRIPS
K
84
0945
SKIN CLOSURE
K
84
2621
SUTURE STRIP
K
83
3258
SKIN TECH. SURGI-STRIPS
K
83
3083
DERMA STRIP-TM SKIN CLOSURES
K
83
1438
ELASTOPLAST
K
83
1439
ELASTOPLAST T.P.N.
K
82
1763
SHUR-STRIP APPLICATOR
K
80
2385
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K
80
2384
CENTRAL VENOUS CATHETER DRESSING TRAY
K
80
1837
PLASTIC STRIP BANDAGES
K
80
1884
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
K
79
2725
FIXOMULL
K
79
2726
LEUKOFIX POROS
K
79
2667
LEUKOCLIP POROS
K
79
2136
HYPO-ALLERGENIC PLASTIC TAPE
K
79
2360
HANSAPOR STERILE
K
79
0140
SKIN CLOSURE TAPES STERILE
K
78
2003
BAND AID* ADHESIVE BANDAGES
K
78
1952
PAPER TAPE, HYPO ALLERGENIC
K
78
0565
SUTURELESS SKIN CLOSURE
K
77
2020
CLOTH ADHESIVE TAPE
K
77
1125
POLYURETHANE PROD. FOR I.V. NEEDLES
K
77
0533
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K
77
0081
BAND-AID BRAND OF ADHESIVE BANDAGES
K
77
0339
BANDAGE, PLASTIC & SHEER
K
77
0180
SUB. OF DIACETONE ACRYLAMIDE
FPY
Sheet, Burn
KGX
Tape And Bandage, Adhesive
KMF
Bandage, Liquid
LRS
I.V. Start Kit
MCY
Wound Dressing Kit
MHW
Dressing, Compression
NEC
Bandage, Liquid, Skin Protectant
OXQ
Dressing Change Tray
PYO
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FPX
/
K801837
View Source
PLASTIC STRIP BANDAGES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K801837
510(k) Type
Traditional
Applicant
MARTIN'S MAINE EXCHANGE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/1980
Days to Decision
91 days