The following data is part of a premarket notification filed by Degussa Ag with the FDA for Dental-quecksilber (dental Mercury).
Device ID | K902388 |
510k Number | K902388 |
Device Name: | DENTAL-QUECKSILBER (DENTAL MERCURY) |
Classification | Mercury |
Applicant | DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
Contact | Mackert |
Correspondent | Mackert DEGUSSA AG POSTFACH 110533 D-6000 FRANKFURT 11 West Germany, DE |
Product Code | ELY |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-30 |
Decision Date | 1990-06-28 |