Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mask, surgical
510(k) Number K210761
Device Name Velguard Surgical Face Mask
Applicant
Esstee Exports Health Care Division
8/3176 A3 & A4, Jothipuram, 2nd Street, Pandian Nagar,
PN Road
Tirupur,  IN 641602
Applicant Contact Zachary Wilson
Correspondent
Pathmaker FDA Law, PLLC
901 Twelve Oaks Center Drive
Wayzata,  MN  55391
Correspondent Contact Amy Fowler
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/15/2021
Decision Date 07/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-