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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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