The following data is part of a premarket notification filed by Ningbo Ouhan Medical Device Co., Ltd. with the FDA for Surgical Mask (procedure Mask) (models: Oh02-01, Oh02-01 (bandage)).
| Device ID | K203418 |
| 510k Number | K203418 |
| Device Name: | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) |
| Classification | Mask, Surgical |
| Applicant | Ningbo Ouhan Medical Device Co., Ltd. No.16, West Ruhu Road, Simen Town Yuyao City, CN 315470 |
| Contact | Annie Annie |
| Correspondent | Rafi Wong Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara, CA 95054 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-09-17 |