The following data is part of a premarket notification filed by Mebo Life Science Inc. with the FDA for Mebo Wound Dressing.
| Device ID | K193439 |
| 510k Number | K193439 |
| Device Name: | MEBO Wound Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | MEBO Life Science Inc. 325 North Puente Street # A Brea, CA 92821 |
| Contact | Sidney Hong |
| Correspondent | Wei Shan Hsu Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CN |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-12-11 |
| Decision Date | 2020-09-04 |