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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 K905269
Device Name OCHSNER 500 VASCULAR PROSTHESIS
Applicant
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760 -3130
Applicant Contact MICHAEL P DAYTON
Correspondent
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760 -3130
Correspondent Contact MICHAEL P DAYTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/23/1990
Decision Date 04/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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