The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Gastro-intestinal System En-410wm.
| Device ID | K993704 |
| 510k Number | K993704 |
| Device Name: | GASTRO-INTESTINAL SYSTEM EN-410WM |
| Classification | Enteroscope And Accessories |
| Applicant | FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Gary Adler |
| Correspondent | Gary Adler FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-02 |
| Decision Date | 2000-02-11 |