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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K844630
Device Name ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
Applicant
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Applicant Contact VAN ANTWERPEN
Correspondent
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Correspondent Contact VAN ANTWERPEN
Regulation Number876.5630
Classification Product Code
FKX  
Date Received11/27/1984
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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