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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 K853148
Device Name HOT OR HEAT PACK
Applicant
Matrix Intl.
244 Brighton Ave.
P.O. Box 700
Boston,  MA  02134
Applicant Contact MARTIN P BIRRITTELL
Correspondent
Matrix Intl.
244 Brighton Ave.
P.O. Box 700
Boston,  MA  02134
Correspondent Contact MARTIN P BIRRITTELL
Regulation Number890.5710
Classification Product Code
IMD  
Date Received07/29/1985
Decision Date 09/25/1985
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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