The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Autoclavable Camer Head Model Otv-y0017.
| Device ID | K102059 |
| 510k Number | K102059 |
| Device Name: | AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-22 |
| Decision Date | 2010-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170336669 | K102059 | 000 |
| 04953170310799 | K102059 | 000 |
| 04953170310782 | K102059 | 000 |