The following data is part of a premarket notification filed by Wellmien (suzhou) Import & Export Trading Co., Ltd with the FDA for Wellmien Surgical Mask.
| Device ID | K101000 |
| 510k Number | K101000 |
| Device Name: | WELLMIEN SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD Pennington, NJ 08534 |
| Contact | Chengyu Shen |
| Correspondent | Chengyu Shen WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD Pennington, NJ 08534 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-08-09 |