The following data is part of a premarket notification filed by Sterngold with the FDA for Sterngold 1, Model 1127781.
| Device ID | K022252 |
| 510k Number | K022252 |
| Device Name: | STERNGOLD 1, MODEL 1127781 |
| Classification | Alloy, Other 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 | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2002-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549100253 | K022252 | 000 |
| 00841549100192 | K022252 | 000 |