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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 K964625
Device Name HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS 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 Received11/15/1996
Decision Date 05/05/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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