The following data is part of a premarket notification filed by Jiangsu Medplus Non-woven Manufacturer Co., Ltd. with the FDA for Standard Procedure Mask, Standard Surgical Mask.
| Device ID | K202605 |
| 510k Number | K202605 |
| Device Name: | Standard Procedure Mask, Standard Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone Siyang, CN 223700 |
| Contact | Shuying An |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971705242846 | K202605 | 000 |
| 16971705242709 | K202605 | 000 |
| 16971705240767 | K202605 | 000 |
| 16971705240712 | K202605 | 000 |