K930859 is an FDA 510(k) clearance for the ROBI COMBI. This device is classified as a Detectors And Removers, Lice, (including Combs) (Class I - General Controls, product code LJL).
Submitted by Epilady 2000, LLC (Washington D.C., US). The FDA issued a Cleared decision on February 28, 1994, 375 days after receiving the submission on February 18, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5960.
| 510(k) Number | K930859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1993 |
| Decision Date | February 28, 1994 |
| Days to Decision | 375 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJL - Detectors And Removers, Lice, (including Combs) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5960 |