510(k) K190541

MTS225 and MTS300 Multiple Tray Sterilization Systems by Pmbs, LLC — Product Code KCT

K190541 is an FDA 510(k) premarket notification submitted by Pmbs, LLC for the device "MTS225 and MTS300 Multiple Tray Sterilization Systems". The FDA issued a decision of Substantially Equivalent on November 5, 2019. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Pmbs, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
March 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type