The following data is part of a premarket notification filed by Peregrine Surgical, Ltd. with the FDA for Peregrine Curved Illuminating Laser Probe.
| Device ID | K132614 |
| 510k Number | K132614 |
| Device Name: | PEREGRINE CURVED ILLUMINATING LASER PROBE |
| Classification | Photocoagulator And Accessories |
| Applicant | PEREGRINE SURGICAL, LTD. 51 Britain Drive Doylestown, PA 18901 |
| Contact | Ryan O'leary |
| Correspondent | Ryan O'leary PEREGRINE SURGICAL, LTD. 51 Britain Drive Doylestown, PA 18901 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-21 |
| Decision Date | 2013-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307002172 | K132614 | 000 |
| 10632307000925 | K132614 | 000 |
| 10632307002349 | K132614 | 000 |
| 00632307002335 | K132614 | 000 |
| 10632307002325 | K132614 | 000 |