The following data is part of a premarket notification filed by 3m Deutschland Gmbh with the FDA for Xp202.
Device ID | K161922 |
510k Number | K161922 |
Device Name: | XP202 |
Classification | Powder, Porcelain |
Applicant | 3M DEUTSCHLAND GMBH ESPE PLATZ Seefeld, DE 82229 |
Contact | Ruediger Franke |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2016-07-13 |
Decision Date | 2016-09-01 |
Summary: | summary |