The following data is part of a premarket notification filed by Vident with the FDA for Palladius-6 Alloy Semi-precious Alloy.
Device ID | K931090 |
510k Number | K931090 |
Device Name: | PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY |
Classification | Alloy, Gold-based Noble Metal |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | Ray E Morrow |
Correspondent | Ray E Morrow VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-03 |
Decision Date | 1993-05-25 |