The following data is part of a premarket notification filed by Gel-e, Inc. with the FDA for Gel-e Flex+.
| Device ID | K182811 |
| 510k Number | K182811 |
| Device Name: | Gel-e Flex+ |
| Classification | Dressing, Wound, Drug |
| Applicant | gel-e, Inc. 387 Technology Dr., Ste 3110B College Park, MD 20742 |
| Contact | Elsa Abruzzo |
| Correspondent | Elsa Abruzzo gel-e, Inc. 387 Technology Dr, Ste 3110B College Park, MD 20742 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-10-03 |
| Decision Date | 2019-08-29 |