The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for I/a Kit.
| Device ID | K831159 |
| 510k Number | K831159 |
| Device Name: | I/A KIT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | STAAR SURGICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-11 |
| Decision Date | 1983-04-28 |