The following data is part of a premarket notification filed by Williams Gold Refining Co., Inc. with the FDA for 14 Karat Casting Gold.
Device ID | K790866 |
510k Number | K790866 |
Device Name: | 14 KARAT CASTING GOLD |
Classification | Alloy, Gold-based Noble Metal |
Applicant | WILLIAMS GOLD REFINING CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-07 |
Decision Date | 1979-06-15 |