The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Minigold.
Device ID | K905326 |
510k Number | K905326 |
Device Name: | MINIGOLD |
Classification | Alloy, Gold-based Noble Metal |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Gary L Severance |
Correspondent | Gary L Severance IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1990-12-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINIGOLD 73017568 1007779 Live/Registered |
WILLIAMS GOLD REFINING COMPANY, INCORPORATED 1974-04-01 |