MODELS DM-360 & DM-350-L SINGLE PATIENT

System, Dialysate Delivery, Single Patient

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Models Dm-360 & Dm-350-l Single Patient.

Pre-market Notification Details

Device IDK792173
510k NumberK792173
Device Name:MODELS DM-360 & DM-350-L SINGLE PATIENT
ClassificationSystem, Dialysate Delivery, Single Patient
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKP  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-29
Decision Date1979-11-16

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