The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Op-con Surgical Instrument #9.
| Device ID | K834169 |
| 510k Number | K834169 |
| Device Name: | OP-CON SURGICAL INSTRUMENT #9 |
| Classification | Forceps, Tube Introduction |
| Applicant | IMM ENTERPRISES LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BWB |
| CFR Regulation Number | 868.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-21 |
| Decision Date | 1984-01-17 |