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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 K990503
Device Name SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
Applicant
Sulzermedica
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact EDWARD E NEWTON
Correspondent
Sulzermedica
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact EDWARD E NEWTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received02/17/1999
Decision Date 12/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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