510(k) K890514
K890514 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "PRE-MOISTENED CLEANSING PAD". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1989
- Date Received
- February 1, 1989
- 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