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 |