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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K905518
Device Name BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
Applicant
Venusa , Ltd.
95 Newfield Ave.
Raritan Center
Edison,  NJ  08837
Applicant Contact LINDA A BELL
Correspondent
Venusa , Ltd.
95 Newfield Ave.
Raritan Center
Edison,  NJ  08837
Correspondent Contact LINDA A BELL
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/07/1990
Decision Date 06/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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