The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Illuminating Laser Probe Model Pd600.10.
Device ID | K031023 |
510k Number | K031023 |
Device Name: | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 |
Classification | Laser, Ophthalmic |
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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-31 |
Decision Date | 2003-06-27 |
Summary: | summary |