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510(k) K864023

EYE PAD, COTTON, GAUZE COVERED by Fraass Survival Systems, Inc.

K864023 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "EYE PAD, COTTON, GAUZE COVERED". The FDA issued a decision of Substantially Equivalent on November 7, 1986. Fraass Survival Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Fraass Survival Systems, Inc.

  • K912022 — FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES (August 2, 1991)
  • K871437 — SURVIVAL KIT, INDIVIDUAL (July 9, 1987)
  • K871434 — MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S (July 9, 1987)
  • K871458 — SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (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)
  • K871438 — BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (May 6, 1987)

FDA data resources