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FDA 510(k) Application Details - K003118
Device Classification Name
Catheter, Flow Directed
More FDA Info for this Device
510(K) Number
K003118
Device Name
Catheter, Flow Directed
Applicant
ZCV ,INC.
298 FERNWOOD AVE.
EDISON, NJ 08837 US
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Contact
JING ZHANG
Other 510(k) Applications for this Contact
Regulation Number
870.1240
More FDA Info for this Regulation Number
Classification Product Code
DYG
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More FDA Info for this Product Code
Date Received
10/05/2000
Decision Date
12/20/2000
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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