The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Co2 Fiberoptic Delivery System/bronchoscopic Use.
| Device ID | K862835 |
| 510k Number | K862835 |
| Device Name: | CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1987-02-05 |