The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Rx Biocast.
| Device ID | K822948 |
| 510k Number | K822948 |
| Device Name: | RX BIOCAST |
| Classification | Alloy, Metal, Base |
| Applicant | JENERIC IND. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-10-22 |