The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Endoscope Contour Detection Device, Model 3dx45 And Colonoscope, Model Xcf-q140l/13d.
| Device ID | K002749 |
| 510k Number | K002749 |
| Device Name: | ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2000-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170165856 | K002749 | 000 |
| 04953170165825 | K002749 | 000 |
| 04953170165849 | K002749 | 000 |
| 04953170077722 | K002749 | 000 |
| 04953170077746 | K002749 | 000 |
| 04953170077753 | K002749 | 000 |
| 04953170077760 | K002749 | 000 |
| 04953170077777 | K002749 | 000 |
| 04953170165740 | K002749 | 000 |
| 04953170165764 | K002749 | 000 |
| 04953170026201 | K002749 | 000 |
| 04953170077708 | K002749 | 000 |
| 04953170077715 | K002749 | 000 |
| 04953170077784 | K002749 | 000 |
| 04953170165801 | K002749 | 000 |