510(k) K142034
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