INDISTRIP GREEN

Indicator, Physical/chemical Sterilization Process

INDILAB, INC.

The following data is part of a premarket notification filed by Indilab, Inc. with the FDA for Indistrip Green.

Pre-market Notification Details

Device IDK110369
510k NumberK110369
Device Name:INDISTRIP GREEN
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant INDILAB, INC. 10367 FRANKLIN AVE. Franklin Park,  IL  60131
ContactMark Espenscheid
CorrespondentMark Espenscheid
INDILAB, INC. 10367 FRANKLIN AVE. Franklin Park,  IL  60131
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-08
Decision Date2011-05-06
Summary:summary

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