510(k) K833993
K833993 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "ALCOHOL SWABS". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1984
- Date Received
- November 21, 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