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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K874034
Device Name ADR-22 AUTOMATIC DIALYZER REPROCESSOR
Applicant
Biodynamics Corp.
6611 Portwest Dr.
Suite 190
Houston,  TX  77024
Applicant Contact RICHARD L BENSON
Correspondent
Biodynamics Corp.
6611 Portwest Dr.
Suite 190
Houston,  TX  77024
Correspondent Contact RICHARD L BENSON
Regulation Number876.5820
Classification Product Code
LIF  
Date Received10/05/1987
Decision Date 10/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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