510(k) K142034

3M STERI-VAC STERILIZER/AERATOR by 3M Company — Product Code FLF

K142034 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M STERI-VAC STERILIZER/AERATOR". The FDA issued a decision of Substantially Equivalent on January 8, 2015. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. 3M Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
July 28, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type