AIRVIEW MINI OWIE DICK TEST PACK

Indicator, Physical/chemical Sterilization Process

CROSSTEX INTERNATIONAL

The following data is part of a premarket notification filed by Crosstex International with the FDA for Airview Mini Owie Dick Test Pack.

Pre-market Notification Details

Device IDK133204
510k NumberK133204
Device Name:AIRVIEW MINI OWIE DICK TEST PACK
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant CROSSTEX INTERNATIONAL 6789 WEST HENRIETTA ROAD Rush,  NY  14543
ContactMichael G Nolan
CorrespondentMichael G Nolan
CROSSTEX INTERNATIONAL 6789 WEST HENRIETTA ROAD Rush,  NY  14543
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-05-05
Summary:summary

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