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FDA 510(k) Application Details - K955887
Device Classification Name
System, Phonocatheter, Intracavitary
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510(K) Number
K955887
Device Name
System, Phonocatheter, Intracavitary
Applicant
NEWMED CORP.
1575 EYE ST., N.W.
WASHINGTON, DC 20005 US
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Contact
DONALD R STONE
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
12/28/1995
Decision Date
09/05/1996
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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