THERMOCHEM-HT SYSTEM

Warmer, Peritoneal Dialysate

HEMOCLEANSE, INC.

The following data is part of a premarket notification filed by Hemocleanse, Inc. with the FDA for Thermochem-ht System.

Pre-market Notification Details

Device IDK993330
510k NumberK993330
Device Name:THERMOCHEM-HT SYSTEM
ClassificationWarmer, Peritoneal Dialysate
Applicant HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette,  IN  47906
ContactStephen R Ash
CorrespondentStephen R Ash
HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette,  IN  47906
Product CodeMLW  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-04
Decision Date1999-12-30
Summary:summary

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