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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 K955382
Device Name 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
Applicant
3M Company
Bldg.s 251-3 And 270
St. Paul,  MN  55144 -1000
Applicant Contact DOROTHEA VON BUSCH
Correspondent
3M Company
Bldg.s 251-3 And 270
St. Paul,  MN  55144 -1000
Correspondent Contact DOROTHEA VON BUSCH
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/24/1995
Decision Date 05/01/1996
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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