The following data is part of a premarket notification filed by 3m Espe Ag with the FDA for Flash Penta Mb Quick, Flash Mb Quick.
Device ID | K140602 |
510k Number | K140602 |
Device Name: | FLASH PENTA MB QUICK, FLASH MB QUICK |
Classification | Material, Impression |
Applicant | 3M ESPE AG ESPE PLATZ Seefeld, DE D-82229 |
Contact | Ruediger Franke |
Correspondent | Ruediger Franke 3M ESPE AG ESPE PLATZ Seefeld, DE D-82229 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-10 |
Decision Date | 2014-06-05 |
Summary: | summary |