The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Cat. 4-obstetrics Gynecology Dev's.
| Device ID | K840308 |
| 510k Number | K840308 |
| Device Name: | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S |
| Classification | Instrument, Manual, General Obstetric-gynecologic |
| Applicant | IMM ENTERPRISES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOH |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-05 |