The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam Waveguide.
| Device ID | K895656 |
| 510k Number | K895656 |
| Device Name: | ACCU-BEAM WAVEGUIDE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Lowell Crow |
| Correspondent | Lowell Crow TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-19 |
| Decision Date | 1990-02-22 |