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FDA 510(k) Application Details - K003446
Device Classification Name
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
More FDA Info for this Device
510(K) Number
K003446
Device Name
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Applicant
ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact
ROBERT L SHERIDAN
Other 510(k) Applications for this Contact
Regulation Number
878.4300
More FDA Info for this Regulation Number
Classification Product Code
NCA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2000
Decision Date
05/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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