The following data is part of a premarket notification filed by Welspun India Limited with the FDA for Welspun Health Surgical Mask.
| Device ID | K211536 |
| 510k Number | K211536 |
| Device Name: | Welspun Health Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Welspun India Limited Survey No. 719, Village: Versamedi, Tal: Anjar District:kutch, IN 370 110 |
| Contact | Satyapriya Dash |
| Correspondent | Manoj Zacharias Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, IL 60504 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-18 |
| Decision Date | 2021-09-01 |