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510(k) K871458

SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW by Fraass Survival Systems, Inc. — Product Code KDD

K871458 is an FDA 510(k) premarket notification submitted by Fraass Survival Systems, Inc. for the device "SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Fraass Survival Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
April 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
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)
  • 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)
  • K871438 — BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (May 6, 1987)
  • K870240 — COMPRESS AND SKULLCAP, HEAD DRESSING (February 20, 1987)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources