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510(k) K964029

EMERGENCY RELIEF KIT SYSTEM by Baxter Healthcare Corp — Product Code LRR

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 17, 1997
Date Received
October 7, 1996
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.

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Other clearances for product code LRR

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