STATClave G4 Chamber Autoclave

Sterilizer, Steam

SciCan Ltd.

The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statclave G4 Chamber Autoclave.

Pre-market Notification Details

Device IDK192910
510k NumberK192910
Device Name:STATClave G4 Chamber Autoclave
ClassificationSterilizer, Steam
Applicant SciCan Ltd. 1440 Don Mills Road Toronto,  CA M3b 3p9
ContactTeresa Boyce
CorrespondentTeresa Boyce
SciCan Ltd. 1440 Don Mills Road Toronto,  CA M3b 3p9
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2020-06-19

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