The following data is part of a premarket notification filed by Degussa Corp. with the FDA for Bond-on 4.
Device ID | K951783 |
510k Number | K951783 |
Device Name: | BOND-ON 4 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DEGUSSA CORP. 3900 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | H. Meinicke |
Correspondent | H. Meinicke DEGUSSA CORP. 3900 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-17 |
Decision Date | 1995-06-02 |