510(k) K792660
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- 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