The following data is part of a premarket notification filed by Care Technologies, Inc. with the FDA for Clear (tm) Special Nit Comb.
| Device ID | K981037 |
| 510k Number | K981037 |
| Device Name: | CLEAR (TM) SPECIAL NIT COMB |
| Classification | Detectors And Removers, Lice, (including Combs) |
| Applicant | CARE TECHNOLOGIES, INC. 2000 M ST. NW (#700) Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli CARE TECHNOLOGIES, INC. 2000 M ST. NW (#700) Washington, DC 20036 |
| Product Code | LJL |
| CFR Regulation Number | 880.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-05-22 |
| Summary: | summary |