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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 K120011
Device Name HEISENBERG EFFECT SHADES
Applicant
3M Espe AG
Espe Platz
Seefeld,  DE 82229
Applicant Contact DESI W SOEGIARTO
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact NORBERT STUIBER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/03/2012
Decision Date 01/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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