The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Video Laparoscope-additional Intended Use.
| Device ID | K925599 |
| 510k Number | K925599 |
| Device Name: | FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1993-07-28 |