The following data is part of a premarket notification filed by Gel-e, Inc. (formerly Remedium Technologies, Inc.) with the FDA for Gel-e Bandage.
| Device ID | K172010 |
| 510k Number | K172010 |
| Device Name: | Gel-e Bandage |
| Classification | Dressing, Wound, Drug |
| Applicant | gel-e, Inc. (formerly Remedium Technologies, Inc.) 387 Technology Dr., Ste 3110B College Park, MD 20742 |
| Contact | Matthew Dowling |
| Correspondent | Elsa Abruzzo Cyngus Regulatory Cincinnati, OH 45226 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-12-07 |
| Summary: | summary |