SteriTite Container System With MediTray Products

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Case Medical, Inc.

The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Container System With Meditray Products.

Pre-market Notification Details

Device IDK212711
510k NumberK212711
Device Name:SteriTite Container System With MediTray Products
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Case Medical, Inc. 50 West Street Bloomfield,  NJ  07003
ContactMichael Polozani
CorrespondentMichael Polozani
Case Medical, Inc. 50 West Street Bloomfield,  NJ  07003
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-26
Decision Date2022-04-29

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