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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K981325
Device Name 3M M.G. MATERIAL
Applicant
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144 -1000
Applicant Contact AMY E FOWLER
Correspondent
3M Company
3m Center
Bldg. 275-3se-08
St. Paul,  MN  55144 -1000
Correspondent Contact AMY E FOWLER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/13/1998
Decision Date 06/11/1998
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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