FDA 510(k) Application Details - K011589

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

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510(K) Number K011589
Device Name Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Applicant BYPASS LTD.
555 THIRTEENTH ST. NW
WASHINGTON, DC 20004-1109 US
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Contact JONATHAN S KAHAN
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Regulation Number 878.4300

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Classification Product Code NCA
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Date Received 05/23/2001
Decision Date 12/26/2001
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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