The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Evl-f (tentative) And Trocar.
| Device ID | K902197 |
| 510k Number | K902197 |
| Device Name: | FUJINON EVL-F (TENTATIVE) AND TROCAR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | FUJINON, INC. SUITE 750 2001 L STREET, N.W. Washington, DC 20036 |
| Contact | J Marks |
| Correspondent | J Marks FUJINON, INC. SUITE 750 2001 L STREET, N.W. Washington, DC 20036 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1991-03-05 |