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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K063023
Device Name 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
Applicant
3M Company
3m Center Bldg. 275-05w-06
St. Paul,  MN  55144
Applicant Contact DIANNE GIBBS
Correspondent
3M Company
3m Center Bldg. 275-05w-06
St. Paul,  MN  55144
Correspondent Contact DIANNE GIBBS
Regulation Number878.4040
Classification Product Code
MSH  
Date Received10/02/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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