The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Heisenberg Effect Shades.
Device ID | K120011 |
510k Number | K120011 |
Device Name: | HEISENBERG EFFECT SHADES |
Classification | Powder, Porcelain |
Applicant | 3M ESPE AG ESPE PLATZ Seefeld, DE 82229 |
Contact | Desi W Soegiarto |
Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-01-03 |
Decision Date | 2012-01-13 |
Summary: | summary |