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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 K912715
Device Name INSTANT WARM GEL PACK
Applicant
Prism Technologies, Inc.
3111 N. Knox Ave.
Chicago,  IL  60641
Applicant Contact CHARLES F MANKER
Correspondent
Prism Technologies, Inc.
3111 N. Knox Ave.
Chicago,  IL  60641
Correspondent Contact CHARLES F MANKER
Regulation Number890.5710
Classification Product Code
IMD  
Date Received06/18/1991
Decision Date 10/02/1991
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
Recalls CDRH Recalls
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