The following data is part of a premarket notification filed by Freudenberg Performance Materials Lp with the FDA for Freudenberg Surgical Mask.
| Device ID | K210063 |
| 510k Number | K210063 |
| Device Name: | Freudenberg Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Freudenberg Performance Materials LP 3500 Industrial Drive Durham, NC 27704 |
| Contact | Eberhard Link |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850024185009 | K210063 | 000 |