The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Cat 15-hematology & Pathology Device.
| Device ID | K840319 |
| 510k Number | K840319 |
| Device Name: | CAT 15-HEMATOLOGY & PATHOLOGY DEVICE |
| Classification | Forceps |
| Applicant | IMM ENTERPRISES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-12 |