The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Clinpro Prophy Powder.
Device ID | K140684 |
510k Number | K140684 |
Device Name: | CLINPRO PROPHY POWDER |
Classification | Prophy Powder, Airbrush Accessory |
Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE D-82229 |
Product Code | PIP |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-18 |
Decision Date | 2014-10-24 |
Summary: | summary |