Home / 510(k) Clearances / K871438

510(k) K871438

BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 by Fraass Survival Systems, Inc. — Product Code EFQ

K871438 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Fraass Survival Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
April 13, 1987
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)
  • K871437 — SURVIVAL KIT, INDIVIDUAL (July 9, 1987)
  • K871458 — SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (July 9, 1987)
  • K871434 — MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S (July 9, 1987)
  • K871916 — FRASTEC DRY BURN DRESSING (June 16, 1987)
  • K871917 — FRASTEC DRY GAUZE BANDAGE (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)
  • K870240 — COMPRESS AND SKULLCAP, HEAD DRESSING (February 20, 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)

FDA data resources