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FDA 510(k) Application Details - K972020
Device Classification Name
System, Phonocatheter, Intracavitary
More FDA Info for this Device
510(K) Number
K972020
Device Name
System, Phonocatheter, Intracavitary
Applicant
CAS MEDICAL SYSTEMS, INC.
21 BUSINESS PARK DR.
BRANFORD, CT 06405 US
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Contact
RON JEFFREY
Other 510(k) Applications for this Contact
Regulation Number
870.1270
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Classification Product Code
DXW
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More FDA Info for this Product Code
Date Received
06/02/1997
Decision Date
05/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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