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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 K912911
Device Name LOW POROSITY (LP) 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 Received07/02/1991
Decision Date 09/23/1991
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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