The following data is part of a premarket notification filed by Gateway Alloys, Inc. with the FDA for Aurora 53.
| Device ID | K964949 |
| 510k Number | K964949 |
| Device Name: | AURORA 53 |
| 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 | 1996-12-10 |
| Decision Date | 1997-01-13 |