CD HOME DIALYSERVICE HEMODIALYSIS TRAY

Accessories, Blood Circuit, Hemodialysis

CD MEDICAL, INC.

The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Cd Home Dialyservice Hemodialysis Tray.

Pre-market Notification Details

Device IDK925654
510k NumberK925654
Device Name:CD HOME DIALYSERVICE HEMODIALYSIS TRAY
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactDiana Uhl
CorrespondentDiana Uhl
CD MEDICAL, INC. 14620 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-09
Decision Date1994-03-30

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