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 |