The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for V.f.i.-viscous Fluid Infusion Tubing Set.
| Device ID | K981907 |
| 510k Number | K981907 |
| Device Name: | V.F.I.-VISCOUS FLUID INFUSION TUBING SET |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-08-04 |
| Summary: | summary |