Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview 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
- FPYSheet, Burn1Product Code
- KGXTape And Bandage, Adhesive1Product Code
- K001240SERAGARD INJECTION PATCH1Cleared 510(K)
- K983368CARE BAND ANTIBACTERIAL BANDAGES1Cleared 510(K)
- K972914SYVEK PATCH1Cleared 510(K)
- K943314ADHESIVE BANDAGES WITH OTC DRUG1Cleared 510(K)
- K952606TARGETT PATCH1Cleared 510(K)
- K954007PARALLEL1Cleared 510(K)
- K944587DERMIVIEW HYPOALLERGENIC CLEAR TAPE1Cleared 510(K)
- K944588STERILE PLASTIC DRESSING1Cleared 510(K)
- K941788BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP1Cleared 510(K)
- K940536BAND-AID(TM) BRAND ADHESIVE BANDAGE1Cleared 510(K)
- Show All 184 Submissions
- 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
SYVEK PATCH
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K972914
- 510(k) Type
- Traditional
- Applicant
- MARINE POLYMER TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/1997
- Days to Decision
- 137 days
- Submission Type
- Statement