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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Blood Pressure Cuff
510(k) Number K962655
Device Name ANEROID AND MERCURIAL SPHYGMOMANOMETERS
Applicant
American Diagnostic Corp.
93 Otis St.
West Babylon,  NY  11704
Applicant Contact MARC BLITSTEIN
Correspondent
American Diagnostic Corp.
93 Otis St.
West Babylon,  NY  11704
Correspondent Contact MARC BLITSTEIN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/08/1996
Decision Date 01/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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