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510(k) K963602

BIODERM PVP FOAM WOUND DRESSING by Bioderm, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1996
Date Received
September 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Bioderm, Inc.

  • K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING (May 18, 1999)
  • K982778 — BIODERM FOAM WOUND DRESSING (October 21, 1998)
  • K982939 — BTF THIN FILM WOUND DRESSING (October 13, 1998)
  • K980451 — BIODERM CALCIUM ALGINATE DRESSING (April 9, 1998)
  • K973429 — BIODERM FOAM WOUND DRESSING (December 1, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)
  • K951842 — BIODERM MEDICAL TRANSPARENT FILM DRESSING (June 12, 1995)
  • K950685 — BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING (June 9, 1995)
  • K950619 — BIODERM MEDICAL FOAM WOUND DRESSING (April 25, 1995)

Other clearances for product code KMF

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  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)