The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Video Laparoscope, Modified.
| Device ID | K930297 |
| 510k Number | K930297 |
| Device Name: | FUJINON VIDEO LAPAROSCOPE, MODIFIED |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Frederic B Rose |
| Correspondent | Frederic B Rose FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-21 |
| Decision Date | 1994-03-29 |