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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 K810376
Device Name MEADOX SZILAGYI GRAFT
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3450
Classification Product Code
DSY  
Date Received02/12/1981
Decision Date 03/05/1981
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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