The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Optiport Vitrectomy Probe Model Pd500.20.
| Device ID | K980399 |
| 510k Number | K980399 |
| Device Name: | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | PEREGRINE SURGICAL LTD. 4050D SKYRON DR. Doylestown, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 4050D SKYRON DR. Doylestown, PA 18901 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-04-30 |
| Summary: | summary |