MOD. DM-357 BICARBONATE RETROFIT KIT

Subsystem, Proportioning

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Mod. Dm-357 Bicarbonate Retrofit Kit.

Pre-market Notification Details

Device IDK800772
510k NumberK800772
Device Name:MOD. DM-357 BICARBONATE RETROFIT KIT
ClassificationSubsystem, Proportioning
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFKR  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-07
Decision Date1980-05-14

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