The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Fiber Optic Bipolar Straight Pick And Angled Pick, Models Pd100.12 And Pd100.13.
| Device ID | K980530 |
| 510k Number | K980530 |
| Device Name: | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 |
| Classification | Endoilluminator |
| 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 | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307001359 | K980530 | 000 |