Dimesol Tubing Sets For Hemodialysis

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

Dimesol, Inc.

The following data is part of a premarket notification filed by Dimesol, Inc. with the FDA for Dimesol Tubing Sets For Hemodialysis.

Pre-market Notification Details

Device IDK171952
510k NumberK171952
Device Name:Dimesol Tubing Sets For Hemodialysis
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant Dimesol, Inc. 509 Fishing Creek Road Lewisberry,  PA  17339
ContactStephen P. Callaghan
CorrespondentCourtney J. Miller
Frost Brown Todd LLC 10 West Broad Street, Suite 2300 Columbus,  OH  43215
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-29
Decision Date2018-03-30
Summary:summary

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