The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Illuminating Laser Probe Model Pd600.10.
| Device ID | K031023 |
| 510k Number | K031023 |
| Device Name: | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 |
| Classification | Laser, Ophthalmic |
| Applicant | PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-06-27 |
| Summary: | summary |