The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for H40 Base Metal Alloy.
| Device ID | K854878 |
| 510k Number | K854878 |
| Device Name: | H40 BASE METAL ALLOY |
| Classification | Alloy, Metal, Base |
| Applicant | JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Martin Schulman |
| Correspondent | Martin Schulman JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-01-30 |