The following data is part of a premarket notification filed by Gentell with the FDA for Gentell Hydrogel Spray Gel, Appligard Squeeze.
| Device ID | K990440 |
| 510k Number | K990440 |
| Device Name: | GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | GENTELL 1667 K ST. N.W., SUITE 700 Washington, DC 20006 -1608 |
| Contact | Mark L Itzkoff |
| Correspondent | Mark L Itzkoff GENTELL 1667 K ST. N.W., SUITE 700 Washington, DC 20006 -1608 |
| 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 | 1999-02-11 |
| Decision Date | 1999-08-12 |
| Summary: | summary |