510(k) K983679
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1999
- Date Received
- October 20, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type