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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K811891
Device Name NORELCO MASSAGER PLUS HEAT BELT
Applicant
North American Philips Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
North American Philips Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5660
Classification Product Code
ISA  
Date Received07/01/1981
Decision Date 07/20/1981
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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