3M STERI-VAC STERILIZER/AERATOR

Sterilizer, Ethylene-oxide Gas

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Steri-vac Sterilizer/aerator.

Pre-market Notification Details

Device IDK142034
510k NumberK142034
Device Name:3M STERI-VAC STERILIZER/AERATOR
ClassificationSterilizer, Ethylene-oxide Gas
Applicant 3M COMPANY 3M CENTER, BUILDING 275-SW-06 St. Paul,  MN  55144
ContactMatt Mortensen
CorrespondentMatt Mortensen
3M COMPANY 3M CENTER, BUILDING 275-SW-06 St. Paul,  MN  55144
Product CodeFLF  
CFR Regulation Number880.6860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-28
Decision Date2015-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387767278 K142034 000
50707387767261 K142034 000
50707387767254 K142034 000
50707387767247 K142034 000
00707387787578 K142034 000
00707387787561 K142034 000
00707387787028 K142034 000
00707387787011 K142034 000

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