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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
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
K
91
1132
MULTIPLE, SURGICAL DRAPE PACK
2
Cleared 510(K)
K
91
0468
STERILE DISPOSABLE DRAPE(S)
2
Cleared 510(K)
K
85
4159
ELLIPTI-PUNCH
2
Cleared 510(K)
K
77
2394
KALRN FACE-LIFE SCISSORS
2
Cleared 510(K)
K
77
2395
DAVIS RHYTIDECTOMY
2
Cleared 510(K)
GAX
Tourniquet, Nonpneumatic
1
Product Code
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
SU
/
subpart-f—therapeutic-devices
/
FZI
/
K772394
View Source
KALRN FACE-LIFE SCISSORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K772394
510(k) Type
Traditional
Applicant
EDWARD WECK, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/9/1978
Days to Decision
72 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
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
FZI
Apparatus, Air Handling, Enclosure
K
91
1132
MULTIPLE, SURGICAL DRAPE PACK
K
91
0468
STERILE DISPOSABLE DRAPE(S)
K
85
4159
ELLIPTI-PUNCH
K
77
2394
KALRN FACE-LIFE SCISSORS
K
77
2395
DAVIS RHYTIDECTOMY
GAX
Tourniquet, Nonpneumatic
KCW
Epilator, High Frequency, Needle-Type
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—therapeutic-devices
/
FZI
/
K772394
View Source
KALRN FACE-LIFE SCISSORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K772394
510(k) Type
Traditional
Applicant
EDWARD WECK, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/9/1978
Days to Decision
72 days