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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 K910182
Device Name 3M BRAND EAR LOOP FACE MASK, 2000F
Applicant
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Applicant Contact PAUL A BURGIO
Correspondent
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Correspondent Contact PAUL A BURGIO
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/15/1991
Decision Date 03/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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