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 n95 respirator with antimicrobial/antiviral agent
510(k) Number K122702
Device Name BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Applicant
FILLIGENT LIMITED
7TH FLLOR, 69 JERVOIS STREET,
SHEUNG WAN
HONG KONG,  CN HK
Applicant Contact KAI DEUSCH
Correspondent
FILLIGENT LIMITED
7TH FLLOR, 69 JERVOIS STREET,
SHEUNG WAN
HONG KONG,  CN HK
Correspondent Contact KAI DEUSCH
Regulation Number878.4040
Classification Product Code
ONT  
Date Received09/04/2012
Decision Date 03/18/2013
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
-
-