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FDA 510(k) Application Details - K060321
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K060321
Device Name
Stethoscope, Electronic
Applicant
AMERICAN DIAGNOSTIC CORP.
55 COMMERCE DR.
HAUPPAUGE, NY 11788 US
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Contact
MICHAEL FALCO
Other 510(k) Applications for this Contact
Regulation Number
870.1875
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Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/09/2006
Decision Date
05/15/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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