Standard Sterilizable Tray

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Implant Direct Sybron Manufacturing, LLC

The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Standard Sterilizable Tray.

Pre-market Notification Details

Device IDK202524
510k NumberK202524
Device Name:Standard Sterilizable Tray
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentReina Choi
Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2021-01-28

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