MTS225 And MTS300 Multiple Tray Sterilization Systems

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

PMBS, LLC

The following data is part of a premarket notification filed by Pmbs, Llc with the FDA for Mts225 And Mts300 Multiple Tray Sterilization Systems.

Pre-market Notification Details

Device IDK190541
501k NumberK190541
Device Name:MTS225 And MTS300 Multiple Tray Sterilization Systems
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant PMBS, LLC 5419 Delette Avenue South St. Petersburg,  FL  33707
ContactMichele E. Mauzerall
CorrespondentAnnette M. Hillring
Hillring & Associates, Inc 3012 St. Charles Drive Tampa,  FL  33618
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-11-05

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