The following data is part of a premarket notification filed by Degussa Corp. with the FDA for Stabilor Hn.
Device ID | K973288 |
510k Number | K973288 |
Device Name: | STABILOR HN |
Classification | Alloy, Other Noble Metal |
Applicant | DEGUSSA CORP. 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger Meinicke DEGUSSA CORP. 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 | 1997-09-02 |
Decision Date | 1997-11-19 |