The following data is part of a premarket notification filed by Alm with the FDA for Axcel Surgical Light.
| Device ID | K030906 |
| 510k Number | K030906 |
| Device Name: | AXCEL SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | ALM 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
| Contact | Frederick R Catt |
| Correspondent | Frederick R Catt ALM 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-04-23 |
| Summary: | summary |