The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Diffusion Light Pipe.
| Device ID | K950529 |
| 510k Number | K950529 |
| Device Name: | PEREGRINE DIFFUSION LIGHT PIPE |
| Classification | Transilluminator, Ac-powered |
| Applicant | PEREGRINE SURGICAL LTD. 22 SHORT RD.LVD WEST Doylestown, PA 18901 |
| Contact | John E Richmond |
| Correspondent | John E Richmond PEREGRINE SURGICAL LTD. 22 SHORT RD.LVD WEST Doylestown, PA 18901 |
| Product Code | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-07 |
| Decision Date | 1995-06-07 |