Crosstex VH2O2 Chemical Indicators

Indicator, Physical/chemical Sterilization Process

Crosstex International, Inc. (A Cantel Medical Company)

The following data is part of a premarket notification filed by Crosstex International, Inc. (a Cantel Medical Company) with the FDA for Crosstex Vh2o2 Chemical Indicators.

Pre-market Notification Details

Device IDK200096
510k NumberK200096
Device Name:Crosstex VH2O2 Chemical Indicators
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant Crosstex International, Inc. (A Cantel Medical Company) 6789 W. Henrietta Road Rush,  NY  14543
ContactPablo Martinez
CorrespondentPablo Martinez
Crosstex International, Inc. (A Cantel Medical Company) 10 Ranick Road Hauppauge,  NY  11788
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2021-07-15

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