The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Video Laparoscope -- Modified.
| Device ID | K932312 |
| 510k Number | K932312 |
| Device Name: | FUJINON VIDEO LAPAROSCOPE -- MODIFIED |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| 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 | FET |
| Subsequent Product Code | FAM |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1994-02-16 |