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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 K984294
Device Name MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Applicant
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760 -3130
Applicant Contact JAMES S MILLER
Correspondent
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760 -3130
Correspondent Contact JAMES S MILLER
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/01/1998
Decision Date 02/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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