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
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- 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)
- K842621SUTURE STRIP1Cleared 510(K)
- K833258SKIN TECH. SURGI-STRIPS1Cleared 510(K)
- K833083DERMA STRIP-TM SKIN CLOSURES1Cleared 510(K)
- K831438ELASTOPLAST1Cleared 510(K)
- K831439ELASTOPLAST T.P.N.1Cleared 510(K)
- K821763SHUR-STRIP APPLICATOR1Cleared 510(K)
- K802385CUSTOM DRESSING TRAY-WET TO DRY/MASS.1Cleared 510(K)
- K802384CENTRAL VENOUS CATHETER DRESSING TRAY1Cleared 510(K)
- K801837PLASTIC STRIP BANDAGES1Cleared 510(K)
- K801884OP-SITE SKIN CLOSURE SUTURE ADHESIVE1Cleared 510(K)
- K792725FIXOMULL1Cleared 510(K)
- K792726LEUKOFIX POROS1Cleared 510(K)
- K792667LEUKOCLIP POROS1Cleared 510(K)
- K792136HYPO-ALLERGENIC PLASTIC TAPE1Cleared 510(K)
- K792360HANSAPOR STERILE1Cleared 510(K)
- K790140SKIN CLOSURE TAPES STERILE1Cleared 510(K)
- K782003BAND AID* ADHESIVE BANDAGES1Cleared 510(K)
- K781952PAPER TAPE, HYPO ALLERGENIC1Cleared 510(K)
- K780565SUTURELESS SKIN CLOSURE1Cleared 510(K)
- K772020CLOTH ADHESIVE TAPE1Cleared 510(K)
- K771125POLYURETHANE PROD. FOR I.V. NEEDLES1Cleared 510(K)
- K770533BAND-AID BRAND ADHES. BAND.-SHEER STRIPS1Cleared 510(K)
- K770081BAND-AID BRAND OF ADHESIVE BANDAGES1Cleared 510(K)
- K770339BANDAGE, PLASTIC & SHEER1Cleared 510(K)
- K770180SUB. OF DIACETONE ACRYLAMIDE1Cleared 510(K)
- 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
POLYURETHANE PROD. FOR I.V. NEEDLES
- Page Type
- Cleared 510(K)
- 510(k) Number
- K771125
- 510(k) Type
- Traditional
- Applicant
- DEVON INDUSTRIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/1977
- Days to Decision
- 41 days