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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Healthcare
3m Center
2510 Conway Ave., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact Angie Draper
Correspondent
3M Healthcare
3m Center
2510 Conway Ave., Bldg. 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
Predetermined Change
Control Plan Authorized		 No
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