The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Evl-f.
| Device ID | K912859 |
| 510k Number | K912859 |
| Device Name: | FUJINON EVL-F |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FUJINON, INC. C/O MARKS MURASE & WHITE 400 PARK AVENUE New York, NY 022 |
| Contact | Frederic B Rose |
| Correspondent | Frederic B Rose FUJINON, INC. C/O MARKS MURASE & WHITE 400 PARK AVENUE New York, NY 022 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-27 |
| Decision Date | 1992-01-23 |