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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 K854431
Device Name MEADOX MEDICALS INC. GRAFT SIZER
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Applicant Contact SCOTT MINDREBO
Correspondent
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Correspondent Contact SCOTT MINDREBO
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/05/1985
Decision Date 05/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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