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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 K936084
Device Name OMNI WARM GEL PACKS
Applicant
OMNI THERM, INC.
2338 WELDON PKWY.
ST. LOUIS,  MO  63146
Applicant Contact DALE E WALTERS
Correspondent
OMNI THERM, INC.
2338 WELDON PKWY.
ST. LOUIS,  MO  63146
Correspondent Contact DALE E WALTERS
Regulation Number890.5710
Classification Product Code
IMD  
Date Received12/21/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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