The following data is part of a premarket notification filed by Gateway Alloys, Inc. with the FDA for De Oro 77.
Device ID | K964476 |
510k Number | K964476 |
Device Name: | DE ORO 77 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | GATEWAY ALLOYS, INC. 1702 SCHERER PKWY. St. Charles, MO 63303 |
Contact | John C Constantine |
Correspondent | John C Constantine GATEWAY ALLOYS, INC. 1702 SCHERER PKWY. St. Charles, MO 63303 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-07 |
Decision Date | 1996-12-04 |