The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Kb58-kf.
| Device ID | K922958 |
| 510k Number | K922958 |
| Device Name: | KB58-KF |
| Classification | Alloy, Other Noble Metal |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Arun Prasad |
| Correspondent | Arun Prasad JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1993-02-26 |