The following data is part of a premarket notification filed by 3m Company with the FDA for Relyx Rmgip.
Device ID | K022476 |
510k Number | K022476 |
Device Name: | RELYX RMGIP |
Classification | Cement, Dental |
Applicant | 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Contact | Karen O'malley |
Correspondent | Karen O'malley 3M COMPANY 3M CENTER, BLDG. 260-2B-12 St Paul, MN 55144 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-29 |
Decision Date | 2002-08-02 |
Summary: | summary |