510(k) K912161
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1991
- Date Received
- May 16, 1991
- 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