The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Jakobi Surg. Instruments #11 11/13/14.
| Device ID | K834195 |
| 510k Number | K834195 |
| Device Name: | JAKOBI SURG. INSTRUMENTS #11 11/13/14 |
| Classification | Blade, Scalpel |
| Applicant | IMM ENTERPRISES LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-21 |
| Decision Date | 1984-01-27 |