The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Bacstop Filter Irrigation Supply Kit.
| Device ID | K860544 |
| 510k Number | K860544 |
| Device Name: | BACSTOP FILTER IRRIGATION SUPPLY KIT |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Robert W Callahan |
| Correspondent | Robert W Callahan STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-13 |
| Decision Date | 1986-04-04 |