SporView Rapid Read Biological Indicator

Indicator, Biological Sterilization Process

Crosstex/SPSmedical, A Division Of Cantel Medical

The following data is part of a premarket notification filed by Crosstex/spsmedical, A Division Of Cantel Medical with the FDA for Sporview Rapid Read Biological Indicator.

Pre-market Notification Details

Device IDK172432
510k NumberK172432
Device Name:SporView Rapid Read Biological Indicator
ClassificationIndicator, Biological Sterilization Process
Applicant Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush,  NY  14543
ContactMegan Skaar
CorrespondentMegan Skaar
Crosstex/SPSmedical, A Division Of Cantel Medical 6789 West Henrietta Road Rush,  NY  14543
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-11
Decision Date2017-12-12
Summary:summary

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