The following data is part of a premarket notification filed by Reichert-jung, Inc. with the FDA for Funs-10, Funs-11.
| Device ID | K862551 |
| 510k Number | K862551 |
| Device Name: | FUNS-10, FUNS-11 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Contact | Richard F Taylor |
| Correspondent | Richard F Taylor REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-09-12 |