The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Spherex E.c.t..
| Device ID | K822951 |
| 510k Number | K822951 |
| Device Name: | SPHEREX E.C.T. |
| Classification | Alloy, Amalgam |
| Applicant | JENERIC IND. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-10-26 |