The following data is part of a premarket notification filed by Combe Incorporated with the FDA for Internal Hydrating Gel.
| Device ID | K141718 |
| 510k Number | K141718 |
| Device Name: | INTERNAL HYDRATING GEL |
| Classification | Lubricant, Personal |
| Applicant | COMBE INCORPORATED 1101 WESTCHESTER AVE. White Plains, NY 10604 |
| Contact | Pushpa Rao |
| Correspondent | Pushpa Rao COMBE INCORPORATED 1101 WESTCHESTER AVE. White Plains, NY 10604 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2014-11-13 |
| Summary: | summary |