The following data is part of a premarket notification filed by Forward Science with the FDA for Orapeutic.
| Device ID | K191987 |
| 510k Number | K191987 |
| Device Name: | Orapeutic |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | Forward Science 10401 Greenbough, Ste 100 Stafford, TX 77477 |
| Contact | Brian Pikkula |
| Correspondent | Brian Pikkula Forward Science 10401 Greenbough, Ste 100 Stafford, TX 77477 |
| 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 | 2019-07-25 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORAPEUTIC 90487040 not registered Live/Pending |
Forward Science Holding, Inc. 2021-01-25 |