The following data is part of a premarket notification filed by Np Medical Inc with the FDA for Npro Surgical Mask.
| Device ID | K203265 |
| 510k Number | K203265 |
| Device Name: | NPro Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | NP Medical Inc 101 Union Street Clinton, MA 01510 |
| Contact | Ruthann Rapp |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-11-05 |
| Decision Date | 2021-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004362906 | K203265 | 000 |
| 00860004362913 | K203265 | 000 |