The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Argelite 52+.
| Device ID | K961211 |
| 510k Number | K961211 |
| Device Name: | ARGELITE 52+ |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | ARGEN PRECIOUS METALS, INC. 5855 OBERLIN DR. San Diego, CA 92121 -4718 |
| Contact | Paul Cascone |
| Correspondent | Paul Cascone ARGEN PRECIOUS METALS, INC. 5855 OBERLIN DR. San Diego, CA 92121 -4718 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-28 |
| Decision Date | 1996-04-25 |