The following data is part of a premarket notification filed by Schoelly Imaging, Inc. with the FDA for Flexilux Ii Cystoscope And Hysteroscope.
| Device ID | K060899 |
| 510k Number | K060899 |
| Device Name: | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | SCHOELLY IMAGING, INC. 173 GROVE STREET Worcester, MA 01605 |
| Contact | Boni S Bonneville |
| Correspondent | Boni S Bonneville SCHOELLY IMAGING, INC. 173 GROVE STREET Worcester, MA 01605 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2007-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851925007397 | K060899 | 000 |
| 00851925007373 | K060899 | 000 |
| 00851925007175 | K060899 | 000 |
| 00851925007168 | K060899 | 000 |
| 00851925007151 | K060899 | 000 |
| 00851925007144 | K060899 | 000 |