• 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 K191355
Device Name 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
Applicant
3M Health Care
3M Center, 2510 Conway Ave., Building 275-5W-06
St. Paul,  MN  55144
Applicant Contact Angie Draper
Correspondent
3M Health Care
3M Center, 2510 Conway Ave., Building 275-5W-06
St. Paul,  MN  55144
Correspondent Contact Angie Draper
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/21/2019
Decision Date 09/11/2019
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
-
-