The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Tapered Diffusion Probe.
| Device ID | K980025 |
| 510k Number | K980025 |
| Device Name: | PEREGRINE TAPERED DIFFUSION PROBE |
| 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 | 1998-01-05 |
| Decision Date | 1998-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307001397 | K980025 | 000 |
| 10632307001366 | K980025 | 000 |
| 10632307001304 | K980025 | 000 |
| 10632307001274 | K980025 | 000 |
| 10632307001236 | K980025 | 000 |
| 10632307001151 | K980025 | 000 |
| 10632307001069 | K980025 | 000 |