510(k) K121655
K121655 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD ALCOHOL SWAB". The FDA issued a decision of Substantially Equivalent on March 20, 2013. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
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