The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Rx Apf (casting Alloy).
| Device ID | K890811 |
| 510k Number | K890811 |
| Device Name: | RX APF (CASTING ALLOY) |
| Classification | Alloy, Other Noble Metal |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Prasad, Phd |
| Correspondent | Prasad, Phd 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 | 1989-02-16 |
| Decision Date | 1989-03-17 |