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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 K970843
Device Name INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Applicant
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760
Applicant Contact MELISSA L BILLMAN
Correspondent
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760
Correspondent Contact MELISSA L BILLMAN
Regulation Number870.3450
Classification Product Code
DSY  
Date Received03/07/1997
Decision Date 06/05/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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