The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Gold Core 55.
| Device ID | K993173 |
| 510k Number | K993173 |
| Device Name: | GOLD CORE 55 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-22 |
| Decision Date | 1999-10-26 |
| Summary: | summary |