The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam 300w Xenon Light Source.
| Device ID | K951895 |
| 510k Number | K951895 |
| Device Name: | ACCU-BEAM 300W XENON LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-05-24 |