The following data is part of a premarket notification filed by Pentron Laboratory Technologies with the FDA for Gold Core Plus.
| Device ID | K023499 |
| 510k Number | K023499 |
| Device Name: | GOLD CORE PLUS |
| Classification | Alloy, Metal, Base |
| Applicant | PENTRON LABORATORY TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero PENTRON LABORATORY TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2003-01-13 |
| Summary: | summary |