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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., N.W.
Walker,  MI  49534
Correspondent
MEDIONICS INTERNATIONAL LTD.
4221 Richmond Rd., N.W.
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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