The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Flash (different Materials).
Device ID | K120438 |
510k Number | K120438 |
Device Name: | FLASH (DIFFERENT MATERIALS) |
Classification | Material, Impression |
Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, Bavaria, 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 | 2012-02-13 |
Decision Date | 2012-05-02 |
Summary: | summary |