The following data is part of a premarket notification filed by Pmbs, Llc with the FDA for Mts225 And Mts300 Multiple Tray Sterilization Systems.
Device ID | K190541 |
510k Number | K190541 |
Device Name: | MTS225 And MTS300 Multiple Tray Sterilization Systems |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | PMBS, LLC 5419 Delette Avenue South St. Petersburg, FL 33707 |
Contact | Michele E. 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 | 2019-03-04 |
Decision Date | 2019-11-05 |