The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Straight Laser Probe, Model Pd6000.00.
| Device ID | K024061 |
| 510k Number | K024061 |
| Device Name: | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-09 |
| Decision Date | 2003-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307000000 | K024061 | 000 |
| 10632307000406 | K024061 | 000 |
| 10632307000413 | K024061 | 000 |
| 10632307000642 | K024061 | 000 |
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| 10632307000369 | K024061 | 000 |
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| 10632307001670 | K024061 | 000 |
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| 10632307001748 | K024061 | 000 |
| 10632307001779 | K024061 | 000 |
| 10632307002110 | K024061 | 000 |