510(k) K871376

FIRST AID KIT, VARIOUS SIZES by Fraass Survival Systems, Inc. — Product Code LRR

Clearance Details

Decision: SESD (Substantially Equivalent (with conditions))
Decision Date: June 4, 1987
Date Received: April 7, 1987
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: First Aid Kit With Drug
Device Class: Class N
Regulation Number
Review Panel: SU
Submission Type

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
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 LRR

K964029 — EMERGENCY RELIEF KIT SYSTEM (March 17, 1997)
K952561 — WATER JEL BURN KIT (July 14, 1995)
K940249 — CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (October 3, 1994)
K941311 — FIRST AID/TRUMA KIT (June 14, 1994)
K931058 — TICK-ATTACK(TM) KIT (March 1, 1994)
K931634 — VARIOUS KITS (November 30, 1993)
K921762 — SHAWNEE PRODUCTS KIT I (January 6, 1993)
K903393 — AUTO FIRST-AID KIT FOR AMERICA (January 31, 1991)
K896413 — COMBINATION 6X-MAGNIFIER AND TWEEZERS (February 1, 1990)
K895767 — ORIGINAL TICK KIT/1ST AID KIT (December 22, 1989)