The following data is part of a premarket notification filed by V&q Manufacturing Corporation with the FDA for Non Woven Face Mask (models: Vqn0185w (earloop) And Vqn0185b (ties)).
| Device ID | K173062 |
| 510k Number | K173062 |
| Device Name: | Non Woven Face Mask (Models: VQN0185W (earloop) And VQN0185B (ties)) |
| Classification | Mask, Surgical |
| Applicant | V&Q Manufacturing Corporation #B1614 Optical Valley Time Square, Wuhan, CN 430074 |
| Contact | Jacky Jin |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No 22 Guimiao Road Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970272170043 | K173062 | 000 |
| 06970272170029 | K173062 | 000 |
| 03615140000208 | K173062 | 000 |
| 03615140000185 | K173062 | 000 |
| 03615140003957 | K173062 | 000 |
| 03615140003940 | K173062 | 000 |
| 03615140003933 | K173062 | 000 |
| 03615140000130 | K173062 | 000 |
| 03615140000413 | K173062 | 000 |