510(k) K833183
K833183 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "APLICARE ONE ACETONE ALCOHOL SWABSTICK". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Aplicare, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1983
- Date Received
- September 19, 1983
- 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