The following data is part of a premarket notification filed by Stericube, Llc with the FDA for Stericube® Multiple Tray Sterilization Systems.
Device ID | K222328 |
510k Number | K222328 |
Device Name: | SteriCUBE® Multiple Tray Sterilization Systems |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | SteriCUBE, LLC 2701 Beach Boulevard South Gulfport, FL 33707 |
Contact | Michele Mauzerall |
Correspondent | Annette M Hillring Hillring & Associates, Inc. 3012 St. Charles Drive Tampa, FL 33618 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-08-02 |
Decision Date | 2022-09-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STERICUBE 88399725 5902432 Live/Registered |
Progressive Sterilization, LLC 2019-04-24 |