• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name respirator,surgical
510(k) Number K121069
Device Name 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
Original Applicant
3M COMPANY
3m center, bldg. 275-5w-06
st. paul,  MN  55144 -1000
Original Contact jizhong jin
Regulation Number878.4040
Classification Product Code
MSH  
Date Received04/09/2012
Decision Date 02/11/2013
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
-
-