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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 K880041
Device Name VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
Applicant
D-R Medical Systems, Inc.
252 Livingston St.
Northvale,  NJ  07647
Applicant Contact DURMUS KOCH
Correspondent
D-R Medical Systems, Inc.
252 Livingston St.
Northvale,  NJ  07647
Correspondent Contact DURMUS KOCH
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/05/1988
Decision Date 06/10/1988
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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