The following data is part of a premarket notification filed by Bmg Pharma Llc. with the FDA for Gelx Oral Gel.
| Device ID | K081372 |
| 510k Number | K081372 |
| Device Name: | GELX ORAL GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | BMG PHARMA LLC. 824 HIGHWAY 88 Gardnerville, NV 89460 |
| Contact | William A Goolsbee |
| Correspondent | William A Goolsbee BMG PHARMA LLC. 824 HIGHWAY 88 Gardnerville, NV 89460 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-16 |
| Decision Date | 2009-02-04 |
| Summary: | summary |