The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Mta:angenieux Starpoint Xe Xenon Light Source.
| Device ID | K945102 |
| 510k Number | K945102 |
| Device Name: | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Contact | Susan Nielsen |
| Correspondent | Susan Nielsen ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1994-11-04 |