The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Faulkner Forceps.
| Device ID | K864071 |
| 510k Number | K864071 |
| Device Name: | FAULKNER FORCEPS |
| Classification | Forceps, Ophthalmic |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | William C Ticknor |
| Correspondent | William C Ticknor STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-11-13 |