The following data is part of a premarket notification filed by Master & Frank Enterprise Co., Ltd with the FDA for Master-frank N95 Particulate Respirator.
| Device ID | K172963 |
| 510k Number | K172963 |
| Device Name: | Master-Frank N95 Particulate Respirator |
| Classification | Respirator, Surgical |
| Applicant | Master & Frank Enterprise Co., Ltd Banhu Industrial District Dong Duan, CN 523000 |
| Contact | Shuge Zhao |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973178959016 | K172963 | 000 |