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510(k) K863714

BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES by Fraass Survival Systems, Inc. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Fraass Survival Systems, Inc.

  • K912022 — FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES (August 2, 1991)
  • K871434 — MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S (July 9, 1987)
  • K871458 — SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (July 9, 1987)
  • K871437 — SURVIVAL KIT, INDIVIDUAL (July 9, 1987)
  • K871917 — FRASTEC DRY GAUZE BANDAGE (June 16, 1987)
  • K871916 — FRASTEC DRY BURN DRESSING (June 16, 1987)
  • K871376 — FIRST AID KIT, VARIOUS SIZES (June 4, 1987)
  • K871501 — KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE (June 2, 1987)
  • K871457 — FIRST AID KIT, EYE DRESSING (May 29, 1987)
  • K871438 — BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (May 6, 1987)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)