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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 K993667
Device Name SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
Applicant
Sulzermedica
1300 E. Anderson Ln.
Austin,  TX  78752 -1793
Applicant Contact EDWARD E NEWTON
Correspondent
Sulzermedica
1300 E. Anderson Ln.
Austin,  TX  78752 -1793
Correspondent Contact EDWARD E NEWTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/01/1999
Decision Date 01/28/2000
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
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