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510(k) K964614

ULTRAFERA WOUND DRESSING by American White Cross, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1997
Date Received
November 18, 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 American White Cross, Inc.

  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K854809 — WHITE CROSS STERILE PAD 4IN. X 4IN. (January 13, 1986)
  • K853558 — DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ (September 5, 1985)
  • K853334 — NON-ADHERA ADHESIVE PAD 3X4 (August 21, 1985)
  • K852408 — EXTRA LARGE ADHESIVE STRIPS (July 29, 1985)
  • K852412 — NON-ADHERENT PAD (July 29, 1985)
  • K852462 — TRICOT ADHESIVE BANDAGE (July 26, 1985)
  • K850595 — 3 X 4 NON-ADHERENT PAD (March 11, 1985)

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  • 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)