The following data is part of a premarket notification filed by Steris Corporation with the FDA for Harmony Vled Surgical Lightning System.
| Device ID | K100395 |
| 510k Number | K100395 |
| Device Name: | HARMONY VLED SURGICAL LIGHTNING SYSTEM |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Correspondent | Robert Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151478 | K100395 | 000 |