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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 K852610
Device Name HOT PACK
Applicant
Oriental Medical Supplies, Inc.
1950 Washington St.
Braintree,  MA  02184
Applicant Contact THOMAS RIIHIMAKI
Correspondent
Oriental Medical Supplies, Inc.
1950 Washington St.
Braintree,  MA  02184
Correspondent Contact THOMAS RIIHIMAKI
Regulation Number890.5710
Classification Product Code
IMD  
Date Received06/19/1985
Decision Date 08/12/1985
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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