The following data is part of a premarket notification filed by Diomed, Ltd. with the FDA for Diomed Delta 25.
| Device ID | K063828 |
| 510k Number | K063828 |
| Device Name: | DIOMED DELTA 25 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMED, LTD. CAMBRIDGE RESEARCH PARK BUILDING 2000 Cambridge, Cambridgeshire, GB Cb5 9te |
| Contact | Tim Phipps |
| Correspondent | Tim Phipps DIOMED, LTD. CAMBRIDGE RESEARCH PARK BUILDING 2000 Cambridge, Cambridgeshire, GB Cb5 9te |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-01-25 |
| Summary: | summary |