The following data is part of a premarket notification filed by Canada Endoscope Corporation with the FDA for Cystoscope, Models Ce0004-c, Ce006-c, Ce3004-c, Ce3027-c, Ce7004-c, Ce1204-c, Ce1227-c.
| Device ID | K093725 |
| 510k Number | K093725 |
| Device Name: | CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | CANADA ENDOSCOPE CORPORATION 1590 OAKBURN ST Pickering, On, CA L1v 6m9 |
| Contact | Roger Leclerc |
| Correspondent | Roger Leclerc CANADA ENDOSCOPE CORPORATION 1590 OAKBURN ST Pickering, On, CA L1v 6m9 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-08-30 |
| Summary: | summary |