The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degubond Lite.
Device ID | K912493 |
510k Number | K912493 |
Device Name: | DEGUBOND LITE |
Classification | Alloy, Other Noble Metal |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger Meinicke DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-04 |
Decision Date | 1991-08-20 |