OraCure
Oral Wound Dressing
TBM Corporation
The following data is part of a premarket notification filed by Tbm Corporation with the FDA for Oracure.
Pre-market Notification Details
| Device ID | K183436 |
| 510k Number | K183436 |
| Device Name: | OraCure |
| Classification | Oral Wound Dressing |
| Applicant | TBM Corporation B-301, Gwangju High-tech Center, 313, Cheomadangwagi-ro, Buk-gu Gwangju, KR 61008 |
| Contact | Jae-woong Jeong |
| Correspondent | Ryan Hwang KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | OLR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-11 |
| Decision Date | 2019-09-18 |
| Summary: | summary |
Trademark Results [OraCure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORACURE 87513366 5716421 Live/Registered |
Ashtel Studios Inc 2017-06-30 |
 ORACURE 85507205 4262509 Dead/Cancelled |
Pro Breath MD LLC 2012-01-02 |
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