The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Tv-endoscope, Upper & Lower Gastrointestinal Appl..
| Device ID | K864960 |
| 510k Number | K864960 |
| Device Name: | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. |
| Classification | Endoscope, Flexible |
| 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 | GCQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-02-10 |