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510(k) K963656

FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING by Adri — Product Code KMF

K963656 is an FDA 510(k) premarket notification submitted by Adri for the device "FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on November 12, 1996. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Adri has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1996
Date Received
September 12, 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 Adri

  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K011618 — CALGITROL AG SILVER ALGINATE WOUND DRESSING (November 15, 2002)
  • K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (March 13, 2000)
  • K940404 — ALGINATE FIBER TOPICAL WOUND DRESSING (May 4, 1994)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)

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