The following data is part of a premarket notification filed by Fujifilm Corporaton with the FDA for Fujifilm Video Laparoscope El-r740m30.
| Device ID | K212950 |
| 510k Number | K212950 |
| Device Name: | FUJIFILM Video Laparoscope EL-R740M30 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FUJIFILM Corporaton 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Dhara Buch FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410449720 | K212950 | 000 |