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FDA 510(k) Application Details - K023427
Device Classification Name
Device, Counter-Pulsating, External
More FDA Info for this Device
510(K) Number
K023427
Device Name
Device, Counter-Pulsating, External
Applicant
CARDIOMEDICS, INC.
18872 BARDEEN AVE.
IRVINE, CA 92612 US
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Contact
GARY CLARK
Other 510(k) Applications for this Contact
Regulation Number
870.5225
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Classification Product Code
DRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2002
Decision Date
01/07/2003
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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