The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Imni-ii.
| Device ID | K951983 |
| 510k Number | K951983 |
| Device Name: | IMNI-II |
| Classification | Disinfectant, Medical Devices |
| Applicant | COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
| Contact | Jack Scoville |
| Correspondent | Jack Scoville COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-06-20 |