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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 K903964
Device Name OCHSNER 50 BIFURCATION
Applicant
INTERVASCULAR, INC.
16331 BAY VISTA DR.
CLEARWATER,  FL  33760 -3130
Applicant Contact MICHAEL DAYTON
Correspondent
INTERVASCULAR, INC.
16331 BAY VISTA DR.
CLEARWATER,  FL  33760 -3130
Correspondent Contact MICHAEL DAYTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received08/28/1990
Decision Date 12/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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