The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degucast 40.
Device ID | K922790 |
510k Number | K922790 |
Device Name: | DEGUCAST 40 |
Classification | Alloy, Metal, Base |
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 | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-09 |
Decision Date | 1992-12-03 |