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FDA 510(k) Application Details - K960923
Device Classification Name
Rotator, Prosthetic Heart Valve
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510(K) Number
K960923
Device Name
Rotator, Prosthetic Heart Valve
Applicant
CARBOMEDICS, INC.
1300-C EAST ANDERSON LN.
AUSTIN, TX 78752 US
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Contact
DAVID M MAKANANI
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Regulation Number
000.0000
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Classification Product Code
MOP
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More FDA Info for this Product Code
Date Received
03/06/1996
Decision Date
04/29/1996
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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