Sterisystem Dry-Base Instrument Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

O&M Halyard, Inc

The following data is part of a premarket notification filed by O&m Halyard, Inc with the FDA for Sterisystem Dry-base Instrument Tray.

Pre-market Notification Details

Device IDK203177
510k NumberK203177
Device Name:Sterisystem Dry-Base Instrument Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant O&M Halyard, Inc 1 Edison Drive Alpharetta,  GA  30005
ContactSteven Dowdley
CorrespondentSteven Dowdley
O&M Halyard, Inc 1 Edison Drive Alpharetta,  GA  30005
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-26
Decision Date2022-01-02

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