510(k) K142034

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

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