The following data is part of a premarket notification filed by Nanjing 3h Medical Products Co., Ltd. with the FDA for Surgical Mask (sterile).
Device ID | K211295 |
510k Number | K211295 |
Device Name: | Surgical Mask (sterile) |
Classification | Mask, Surgical |
Applicant | Nanjing 3H Medical Products Co., Ltd. No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing, CN 211300 |
Contact | Chun Yang |
Correspondent | Chun Yang Nanjing 3H Medical Products Co., Ltd. No.5 Zhushan Road Gaochun County Economic Development Zone Nanjing, CN 211300 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-28 |
Decision Date | 2021-11-24 |