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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K992489
Device Name 3M TR SYSTEM
Applicant
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144 -1000
Applicant Contact LAEL J PICKETT
Correspondent
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144 -1000
Correspondent Contact LAEL J PICKETT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/26/1999
Decision Date 01/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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