510(k) K930859
K930859 is an FDA 510(k) premarket notification submitted by Epilady 2000, LLC for the device "ROBI COMBI". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Epilady 2000, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1994
- Date Received
- February 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detectors And Removers, Lice, (Including Combs)
- Device Class
- Class I
- Regulation Number
- 880.5960
- Review Panel
- HO
- Submission Type