The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Cosp2.
Device ID | K093721 |
510k Number | K093721 |
Device Name: | COSP2 |
Classification | Cord, Retraction |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Desi W Soegiarto |
Correspondent | Desi W Soegiarto 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | MVL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-02 |
Decision Date | 2010-02-19 |
Summary: | summary |