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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K854023
Device Name NORELCO ELECTRONIC DIGITAL BP METER HC3501
Applicant
Philips Park
P.O. Box 500
Essex,  CT  06426
Applicant Contact TED FLOWERS
Correspondent
Philips Park
P.O. Box 500
Essex,  CT  06426
Correspondent Contact TED FLOWERS
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/30/1985
Decision Date 03/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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