510(k) K974304
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1998
- Date Received
- November 17, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Medical Devices
- Device Class
- Class I
- Regulation Number
- 880.6890
- Review Panel
- HO
- Submission Type