The following data is part of a premarket notification filed by 3m Company with the FDA for Lcr.
Device ID | K052235 |
510k Number | K052235 |
Device Name: | LCR |
Classification | Cement, Dental |
Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
Contact | Karen O'malley |
Correspondent | Karen O'malley 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-17 |
Decision Date | 2005-09-27 |
Summary: | summary |