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510(k) K940336

CERTI HEAT INSTANT HEAT COMPRESS by Certified Safety Mfg., Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
January 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

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)
  • K941311 — FIRST AID/TRUMA KIT (June 14, 1994)
  • K940358 — X-LARGE MULTI-FUNCTION TRAUMA DRESSING (March 23, 1994)

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