The following data is part of a premarket notification filed by Staar Surgical Company with the FDA for Microstaar Injector System Cartridges.
| Device ID | K152357 |
| 510k Number | K152357 |
| Device Name: | MicroSTAAR Injector System Cartridges |
| Classification | Lens, Guide, Intraocular |
| Applicant | STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840311344796 | K152357 | 000 |