The following data is part of a premarket notification filed by Combe Incorporated with the FDA for External Moisturizing Gel.
| Device ID | K171855 |
| 510k Number | K171855 |
| Device Name: | External Moisturizing Gel |
| Classification | Lubricant, Personal |
| Applicant | Combe Incorporated 1101 Westchester Avenue White Plains, NY 10604 |
| Contact | Richard Grabarz |
| Correspondent | Richard Grabarz Combe Incorporated 1101 Westchester Avenue White Plains, NY 10604 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-21 |
| Decision Date | 2017-07-21 |
| Summary: | summary |