The following data is part of a premarket notification filed by Degussa Corp. with the FDA for Futura One.
Device ID | K950187 |
510k Number | K950187 |
Device Name: | FUTURA ONE |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DEGUSSA CORP. 3900 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger 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 | 1995-01-17 |
Decision Date | 1995-03-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FUTURA ONE 75512639 not registered Dead/Abandoned |
MICROFLEX MEDICAL CORPORATION 1998-07-02 |