510(k) K964835
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1996
- Date Received
- November 25, 1996
- 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