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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, Reusable
510(k) Number K921446
Device Name HOT OR COLD PACK (THERMIPAQ)
Applicant
Thermionics Corp.
828 S. Second St.
Springfield,  IL  62704
Applicant Contact TERRY L PANCAKE
Correspondent
Thermionics Corp.
828 S. Second St.
Springfield,  IL  62704
Correspondent Contact TERRY L PANCAKE
Regulation Number890.5700
Classification Product Code
IME  
Date Received03/27/1992
Decision Date 07/13/1992
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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