The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Xcyf-1t3 Oes Cystofiberscope/nephrofiberscope Accessories And Ancillary Equipment.
| Device ID | K993041 |
| 510k Number | K993041 |
| Device Name: | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | THE OLYMPUS OPTICAL CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Shiff |
| Correspondent | Robert Shiff THE OLYMPUS OPTICAL CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | FAJ |
| Subsequent Product Code | FGA |
| Subsequent Product Code | KGE |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-10 |
| Decision Date | 2000-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170139632 | K993041 | 000 |
| 04953170024474 | K993041 | 000 |
| 04953170024481 | K993041 | 000 |
| 04953170024511 | K993041 | 000 |
| 04953170024528 | K993041 | 000 |
| 14953170049115 | K993041 | 000 |
| 14953170049160 | K993041 | 000 |
| 04953170049170 | K993041 | 000 |
| 14953170049221 | K993041 | 000 |
| 04953170049231 | K993041 | 000 |
| 04953170049248 | K993041 | 000 |
| 14953170049320 | K993041 | 000 |
| 14953170062435 | K993041 | 000 |
| 04953170062445 | K993041 | 000 |
| 14953170062466 | K993041 | 000 |
| 04953170063428 | K993041 | 000 |
| 04953170024467 | K993041 | 000 |