SINGLE PATIENT SYSTEMS

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 Single Patient Systems.

Pre-market Notification Details

Device IDK780682
510k NumberK780682
Device Name:SINGLE PATIENT SYSTEMS
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 Received1978-04-24
Decision Date1978-06-22

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