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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Ostia, Aorto-Saphenous Vein
510(k) Number K864101
Device Name COOK (R) VEIN GRAFT RING MARKERS
Applicant
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact MILES F KANNE
Correspondent
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact MILES F KANNE
Classification Product Code
KPK  
Date Received10/21/1986
Decision Date 10/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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