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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 K910173
Device Name SELECTRA AND TUBING SETS
Applicant
Medionics International , Ltd.
114 Anderson Ave.
Markhlam, Ontario,
Canada L6e 1a5,  CA
Applicant Contact MAHESH AGARWAL
Correspondent
Medionics International , Ltd.
114 Anderson Ave.
Markhlam, Ontario,
Canada L6e 1a5,  CA
Correspondent Contact MAHESH AGARWAL
Regulation Number876.5630
Classification Product Code
FKX  
Date Received01/15/1991
Decision Date 01/13/1992
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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