The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Flexible Ureteroscope Su-7 & Su-9.
| Device ID | K880801 |
| 510k Number | K880801 |
| Device Name: | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Marilyn Waxberg |
| Correspondent | Marilyn Waxberg MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-29 |
| Decision Date | 1988-05-26 |