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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 K832141
Device Name MICROSTAR VC1 VOLUMETRIC CYCLER
Applicant
Medionics International , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medionics International , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5630
Classification Product Code
FKX  
Date Received07/05/1983
Decision Date 10/14/1983
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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