FDA 510(k) Application Details - K003446

Device Classification Name Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

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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
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Regulation Number 878.4300

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Classification Product Code NCA
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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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