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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K961176
Device Name OMNI COLD GEL PACKS
Applicant
Omni Therm, Inc.
2338 Weldon Pkwy.
St. Louis,  MO  63146
Applicant Contact MATT WALTERS
Correspondent
Omni Therm, Inc.
2338 Weldon Pkwy.
St. Louis,  MO  63146
Correspondent Contact MATT WALTERS
Regulation Number890.5710
Classification Product Code
IMD  
Date Received03/25/1996
Decision Date 09/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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