The following data is part of a premarket notification filed by Tti Medical with the FDA for Co2 Laser Bronchoscope Set.
| Device ID | K870063 |
| 510k Number | K870063 |
| Device Name: | CO2 LASER BRONCHOSCOPE SET |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | TTI MEDICAL 3470 MT. DIABLO BLVD. SUITE A 150 Lafayette, CA 94549 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 3470 MT. DIABLO BLVD. SUITE A 150 Lafayette, CA 94549 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-07 |
| Decision Date | 1987-03-09 |