FDA 510(k) Application Details - K830908

Device Classification Name System, Dialysate Delivery, Central Multiple Patient

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510(K) Number K830908
Device Name System, Dialysate Delivery, Central Multiple Patient
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

, US
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Regulation Number 876.5820

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Classification Product Code FKQ
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Date Received 03/21/1983
Decision Date 06/08/1983
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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