The following data is part of a premarket notification filed by E.m. Adams with the FDA for Sterile Solution Bowl.
| Device ID | K843115 |
| 510k Number | K843115 |
| Device Name: | STERILE SOLUTION BOWL |
| Classification | Recorder, Attention Task Performance |
| Applicant | E.M. ADAMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-08 |
| Decision Date | 1984-09-07 |