The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Resin Cement.
Device ID | K952121 |
510k Number | K952121 |
Device Name: | 3M RESIN CEMENT |
Classification | Cement, Dental |
Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-2B-09 St. Paul, MN 55144 -1000 |
Contact | Rebecca L Nannack |
Correspondent | Rebecca L Nannack 3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-2B-09 St. Paul, MN 55144 -1000 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-05 |
Decision Date | 1995-06-22 |