MTS300 Multiple Tray Sterilization System

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 Mts300 Multiple Tray Sterilization System.

Pre-market Notification Details

Device IDK152014
510k NumberK152014
Device Name:MTS300 Multiple Tray Sterilization System
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant PMBS, LLC 40 MILLTOWN ROAD Stockton,  NJ  08559
ContactMichele E. Mauzerall
CorrespondentAnnette M. Hillring
HILLRING & ASSOCIATES, INC. 3012 ST. CHARLES DR. Tampa,  FL  33618
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-21
Decision Date2015-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851489007123 K152014 000
00851489007130 K152014 000
00851489007000 K152014 000
00851489007017 K152014 000
00851489007024 K152014 000
00851489007031 K152014 000
00851489007048 K152014 000
00851489007055 K152014 000
00851489007062 K152014 000
00851489007079 K152014 000
00851489007086 K152014 000
00851489007093 K152014 000
00851489007109 K152014 000
00851489007116 K152014 000
00851489007222 K152014 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.