510(k) K883840
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- May 16, 1989
- Date Received
- September 12, 1988
- 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