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510(k) K954877

OMNI COLD GEL PACKS by Omni Therm, Inc. — Product Code IMD

Clearance Details

Decision
SN ()
Decision Date
February 13, 1996
Date Received
October 24, 1995
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 Omni Therm, Inc.

  • K961176 — OMNI COLD GEL PACKS (September 4, 1996)
  • K955788 — IMNI HOT PACKS (September 4, 1996)
  • K936084 — OMNI WARM GEL PACKS (March 31, 1994)
  • K864853 — OMNI THERM TEMPERATURE MONITOR (February 4, 1987)

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  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)
  • K982652 — ALLEGIANCE PORTA-WARM MATTRESS (January 21, 1999)
  • K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (February 26, 1998)
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