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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 K990800
Device Name INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
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 Received03/10/1999
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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