DIALYSIS TRAY

Accessories, Blood Circuit, Hemodialysis

MEDCARE PRODUCTS

The following data is part of a premarket notification filed by Medcare Products with the FDA for Dialysis Tray.

Pre-market Notification Details

Device IDK841124
510k NumberK841124
Device Name:DIALYSIS TRAY
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant MEDCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-15
Decision Date1984-04-20

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