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 K211487
Device Name MAF Guard
Applicant
Maf Clothing Pvt Ltd Unit-3
Sy. No59/3, 59/4, Rajathadripura, Near K B Cross
Karnataka,  IN 572114
Applicant Contact Kirit Jagani
Correspondent
Benjamin L. England and Associates, LLC
810 Landmark Dr. Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Thomas C. Knott
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/13/2021
Decision Date 12/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-