PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR

Indicator, Physical/chemical Sterilization Process

COTTRELL, LTD.

The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Prochek G Glutaraldehyde Concentration Level Indicator.

Pre-market Notification Details

Device IDK960089
510k NumberK960089
Device Name:PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant COTTRELL, LTD. 49 PLAIN ST. North Attleboro,  MA  02760 -4153
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
COTTRELL, LTD. 49 PLAIN ST. North Attleboro,  MA  02760 -4153
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-11
Decision Date1996-04-04
Summary:summary

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