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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K850569
Device Name BSM 2000 DIALYSIS MACHINE - MODIFIED
Applicant
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Applicant Contact MARTIN ROBERTS
Correspondent
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Correspondent Contact MARTIN ROBERTS
Regulation Number876.5820
Classification Product Code
FKP  
Date Received02/12/1985
Decision Date 03/12/1985
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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