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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 K983819
Device Name INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
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 Received10/29/1998
Decision Date 11/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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