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510(k) K982597

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE by Johnson & Johnson Medical, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1998
Date Received
July 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Johnson & Johnson Medical, Inc.

  • K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX (October 21, 2004)
  • K022483 — ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING (February 3, 2003)
  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)
  • K973699 — ULTRALON POWDER FREE LATEX SURGICAL GLOVE (December 16, 1997)

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