510(k) K121655
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2013
- Date Received
- June 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Alcohol, Device Disinfectant
- Device Class
- Class U
- Regulation Number
- Review Panel
- HO
- Submission Type