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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 K034010
Device Name GELSOFT PLUS ERS
Applicant
VASCUTEK LTD.
6200 JACKSON RD.
ANN ARBOR,  MI  48103 -9300
Applicant Contact STEVEN ARICK
Correspondent
VASCUTEK LTD.
6200 JACKSON RD.
ANN ARBOR,  MI  48103 -9300
Correspondent Contact STEVEN ARICK
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/24/2003
Decision Date 02/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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