510(k) K142454
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2015
- Date Received
- September 2, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Chemical
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type