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 |