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510(k) K941311

FIRST AID/TRUMA KIT by Certified Safety Mfg., Inc. — Product Code LRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1994
Date Received
March 18, 1994
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 Certified Safety Mfg., Inc.

  • K960587 — CPROTECTOR 2000 (July 21, 1997)
  • K960615 — GAUZE COMPRESS (November 25, 1996)
  • K960624 — CERTI COOL INSTANT COLD COMPRESS (May 6, 1996)
  • K953102 — BLOODBORNE PATHOGEN KIT (December 11, 1995)
  • K946338 — CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING (March 29, 1995)
  • K945002 — 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE (March 22, 1995)
  • K945004 — 2, 3 & 4 BANDADGE COMPRESS (March 22, 1995)
  • K940249 — CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (October 3, 1994)
  • K940358 — X-LARGE MULTI-FUNCTION TRAUMA DRESSING (March 23, 1994)
  • K940336 — CERTI HEAT INSTANT HEAT COMPRESS (March 7, 1994)

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)
  • 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)
  • K891483 — FIRST AID SURVIVAL KIT (May 11, 1989)