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FDA 510(k) Application Details - K982419
Device Classification Name
Stabilizer,Heart
More FDA Info for this Device
510(K) Number
K982419
Device Name
Stabilizer,Heart
Applicant
CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO, CA 95014 US
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Contact
MIKE BILLIG
Other 510(k) Applications for this Contact
Regulation Number
870.4500
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Classification Product Code
MWS
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More FDA Info for this Product Code
Date Received
07/13/1998
Decision Date
01/13/1999
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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