510(k) K142034
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