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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K012304
Device Name ADC 656 ELECTRONIC STETHOSCOPE
Applicant
AMERICAN DIAGNOSTIC CORP.
55 COMMERCE DR.
HAUPPAUGE,  NY  11788
Applicant Contact MARC BLITSTEIN
Correspondent
AMERICAN DIAGNOSTIC CORP.
55 COMMERCE DR.
HAUPPAUGE,  NY  11788
Correspondent Contact MARC BLITSTEIN
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/20/2001
Decision Date 11/01/2001
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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