Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- FPXStrip, Adhesive, Closure, Skin1Product Code
- K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH1Cleared 510(K)
- K952947DELPORE SKIN CLOSURE1Cleared 510(K)
- K952702DERMA SEAL1Cleared 510(K)
- K946321BIOSTRIP STERILE WOUND CLOSURE STRIP1Cleared 510(K)
- K931005DUKAL SKIN CLOSURE STRIP1Cleared 510(K)
- K921775SPYROFLEX WOUND CLOSURES1Cleared 510(K)
- K894802AWC BUTTERFLY WOUND CLOSURES1Cleared 510(K)
- K894205TECNOL SILK STRIP1Cleared 510(K)
- K874813OMED WOUND CLOSURE STRIPS1Cleared 510(K)
- K840945SKIN CLOSURE1Cleared 510(K)
Show All 35 Submissions
- FPYSheet, Burn1Product Code
- KGXTape And Bandage, Adhesive1Product Code
- KMFBandage, Liquid1Product Code
- LRSI.V. Start Kit2Product Code
- MCYWound Dressing Kit2Product Code
- MHWDressing, Compression1Product Code
- NECBandage, Liquid, Skin Protectant1Product Code
- OXQDressing Change Tray1Product Code
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use1Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SKIN CLOSURE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K840945
- 510(k) Type
- Traditional
- Applicant
- GAINOR MEDICAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/31/1984
- Days to Decision
- 240 days