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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 K842305
Device Name C.A.P.D. AUTOMATIC HEATER PDH 200
Applicant
MEDIONICS INTERNATIONAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDIONICS INTERNATIONAL LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5630
Classification Product Code
FKX  
Date Received06/12/1984
Decision Date 06/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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