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 |