The following data is part of a premarket notification filed by Sterngold with the FDA for Critertion, Model #1067511.
| Device ID | K021741 |
| 510k Number | K021741 |
| Device Name: | CRITERTION, MODEL #1067511 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Contact | Maria Rao |
| Correspondent | Maria Rao STERNGOLD 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-06-26 |
| Summary: | summary |