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 | K834540 |
| 510k Number | K834540 |
| Device Name: | OP-CON SURGICAL INSTRUMENT #9 |
| Classification | Gag, Mouth |
| Applicant | IMM ENTERPRISES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KBN |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-01 |
| Decision Date | 1984-03-06 |