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510(k) K980451

BIODERM CALCIUM ALGINATE DRESSING by Bioderm, Inc. — Product Code KMF

K980451 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "BIODERM CALCIUM ALGINATE DRESSING". The FDA issued a decision of SN on April 9, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Bioderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 9, 1998
Date Received
February 5, 1998
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)
  • K973429 — BIODERM FOAM WOUND DRESSING (December 1, 1997)
  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K963602 — BIODERM PVP FOAM WOUND DRESSING (October 30, 1996)
  • 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

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • 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)

FDA data resources