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 |