The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Wet Set, Model Pd400.00.
| Device ID | K990518 |
| 510k Number | K990518 |
| Device Name: | PEREGRINE WET SET, MODEL PD400.00 |
| Classification | Pump, Infusion |
| Applicant | PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Contact | John E Richmond |
| Correspondent | John E Richmond PEREGRINE SURGICAL LTD. 4050 D SKYRON DR. Doylestown, PA 18901 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-03-25 |
| Summary: | summary |