The following data is part of a premarket notification filed by F. & F. Koenigkramer with the FDA for Reliance Tempo Ophth. Instr Stand.
| Device ID | K831568 |
| 510k Number | K831568 |
| Device Name: | RELIANCE TEMPO OPHTH. INSTR STAND |
| Classification | Remover, Intrauterine Device, Contraceptive, Hook-type |
| Applicant | F. & F. KOENIGKRAMER 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-06-30 |