The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Flash Ar; Flash Ar Quick.
Device ID | K133436 |
510k Number | K133436 |
Device Name: | FLASH AR; FLASH AR QUICK |
Classification | Material, Impression |
Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, Bavaria, DE 82229 |
Contact | Desi Soegiarto |
Correspondent | Desi Soegiarto 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, Bavaria, DE 82229 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-08 |
Decision Date | 2014-03-07 |
Summary: | summary |