The following data is part of a premarket notification filed by Estee Exports Health Care Division with the FDA for Velguard Surgical Face Mask.
Device ID | K210761 |
510k Number | K210761 |
Device Name: | Velguard Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Estee Exports Health Care Division 8/3176 A3 & A4, Jothipuram, 2nd Street, Pandian Nagar, PN Road Tirupur, IN 641602 |
Contact | Zachary Wilson |
Correspondent | Amy Fowler Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, MN 55391 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-15 |
Decision Date | 2021-07-16 |