The following data is part of a premarket notification filed by Gel-e, Inc. with the FDA for Gel-e Flex+ Gel Otc.
| Device ID | K192667 |
| 510k Number | K192667 |
| Device Name: | Gel-e Flex+ Gel OTC |
| Classification | Dressing, Wound, Drug |
| Applicant | gel-e, Inc. 387 Technology Dr., Suite 3110B College Park, MD 20742 |
| Contact | Elsa Abruzzo |
| Correspondent | Elsa Abruzzo gel-e, Inc. 387 Technology Dr., Suite 3110B College Park, MD 20742 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010047477 | K192667 | 000 |
| 00860010047460 | K192667 | 000 |