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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K760090
Device Name GRAFT, COOLEY GUIDELINE, STERILE
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3450
Classification Product Code
DSY  
Date Received06/21/1976
Decision Date 07/20/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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