The following data is part of a premarket notification filed by Juntech(jiaxing)healthcare Materials Co,.ltd with the FDA for Surgical Face Mask.
| Device ID | K203704 |
| 510k Number | K203704 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Juntech(Jiaxing)Healthcare Materials Co,.Ltd No.4 Plant,No1 Build Of North Of Yubei St, And Zhengdong Rd, Yuxin Town Nanhu District Jiaxing, CN 314009 |
| Contact | Cam Sun |
| Correspondent | Gamma Zhang Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, CN 510000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973140040028 | K203704 | 000 |