The following data is part of a premarket notification filed by Alm S.a. with the FDA for Alm X'ten (x10) Surgical Light System.
| Device ID | K040735 |
| 510k Number | K040735 |
| Device Name: | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | ALM S.A. 1777 EAST HENRIETTA ROAD Rochester, NY 14623 -3133 |
| Contact | Frederick R Catt |
| Correspondent | Frederick R Catt ALM S.A. 1777 EAST HENRIETTA ROAD Rochester, NY 14623 -3133 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-22 |
| Decision Date | 2004-05-21 |
| Summary: | summary |