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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phonocardiograph
510(k) Number K943726
Device Name ACOUSTIC RECORDER
Applicant
Technology Applications Assoc., Inc.
2905 Cowley Way, Suite E
San Diego,  CA  92117
Applicant Contact DAVID V SIRIANO
Correspondent
Technology Applications Assoc., Inc.
2905 Cowley Way, Suite E
San Diego,  CA  92117
Correspondent Contact DAVID V SIRIANO
Regulation Number870.2390
Classification Product Code
DQC  
Date Received08/02/1994
Decision Date 11/30/1994
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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