The following data is part of a premarket notification filed by Ricerfarma Srl with the FDA for Gengigel Mouthrinse.
| Device ID | K053342 |
| 510k Number | K053342 |
| Device Name: | GENGIGEL MOUTHRINSE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | RICERFARMA SRL 303 PATLEIGH ROAD Catonsville, MD 21228 |
| Contact | Paul Ketteridge |
| Correspondent | Paul Ketteridge RICERFARMA SRL 303 PATLEIGH ROAD Catonsville, MD 21228 |
| 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 | 2005-12-01 |
| Decision Date | 2007-03-13 |
| Summary: | summary |