HEISENBERG EFFECT SHADES

Powder, Porcelain

3M ESPE AG

The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Heisenberg Effect Shades.

Pre-market Notification Details

Device IDK120011
510k NumberK120011
Device Name:HEISENBERG EFFECT SHADES
ClassificationPowder, Porcelain
Applicant 3M ESPE AG ESPE PLATZ Seefeld,  DE 82229
ContactDesi W Soegiarto
CorrespondentNorbert Stuiber
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-01-03
Decision Date2012-01-13
Summary:summary

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