The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Modification To Olympus Capsule Endoscope System.
| Device ID | K090210 |
| 510k Number | K090210 |
| Device Name: | MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-28 |
| Decision Date | 2009-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170214325 | K090210 | 000 |
| 14953170230995 | K090210 | 000 |