The following data is part of a premarket notification filed by The Stern Metals Co., Inc. with the FDA for Sterngold G-hard Metal Alloy.
| Device ID | K962301 |
| 510k Number | K962301 |
| Device Name: | STERNGOLD G-HARD METAL ALLOY |
| Classification | Alloy, Other Noble Metal |
| Applicant | THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
| Contact | Nicholas J Savarese |
| Correspondent | Nicholas J Savarese THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-07-18 |