Home / 510(k) Clearances / K871916

510(k) K871916

FRASTEC DRY BURN DRESSING by Fraass Survival Systems, Inc. — Product Code EFQ

K871916 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "FRASTEC DRY BURN DRESSING". The FDA issued a decision of SN on June 16, 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
SN ()
Decision Date
June 16, 1987
Date Received
May 18, 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)
  • K871458 — SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (July 9, 1987)
  • K871434 — MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S (July 9, 1987)
  • K871437 — SURVIVAL KIT, INDIVIDUAL (July 9, 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)
  • K871438 — BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (May 6, 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