The following data is part of a premarket notification filed by Kiel Laboratories, Inc. with the FDA for Klout Shampoo And Lice Combing Pretreatment Kit.
| Device ID | K991958 |
| 510k Number | K991958 |
| Device Name: | KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT |
| Classification | Detectors And Removers, Lice, (including Combs) |
| Applicant | KIEL LABORATORIES, INC. 2225 CENTENNIAL DR. Gainesville, GA 30504 |
| Contact | Tanyja Porcha |
| Correspondent | Tanyja Porcha KIEL LABORATORIES, INC. 2225 CENTENNIAL DR. Gainesville, GA 30504 |
| Product Code | LJL |
| CFR Regulation Number | 880.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-10 |
| Decision Date | 1999-08-13 |
| Summary: | summary |