The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Category 1 Circulatory System Device.
| Device ID | K840305 |
| 510k Number | K840305 |
| Device Name: | CATEGORY 1 CIRCULATORY SYSTEM DEVICE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | IMM ENTERPRISES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-04-23 |