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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Manual
510(k) Number K935944
Device Name PROSCOPES AND ADSCOPES
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 Number870.1875
Classification Product Code
LDE  
Date Received12/13/1993
Decision Date 03/03/1994
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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