FDA 510(k) Application Details - K843623

Device Classification Name System, Dialysate Delivery, Central Multiple Patient

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510(K) Number K843623
Device Name System, Dialysate Delivery, Central Multiple Patient
Applicant MEDICAL ENTERPRISES, LTD.
3925 WEST NORTHSIDE DR.
JACKSON, MS US
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Contact HOLLAND
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Regulation Number 876.5820

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Classification Product Code FKQ
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Date Received 08/21/1984
Decision Date 11/16/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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