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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K013683
Device Name MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
Applicant
ABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City,  CA  94063
Applicant Contact PATTY HEVEY
Correspondent
ABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City,  CA  94063
Correspondent Contact PATTY HEVEY
Regulation Number878.5010
Classification Product Code
GAW  
Date Received11/07/2001
Decision Date 12/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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