The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for I/a Kit.
| Device ID | K830859 |
| 510k Number | K830859 |
| Device Name: | I/A KIT |
| Classification | Catheter, Irrigation |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-17 |
| Decision Date | 1983-05-02 |