The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Injector Nm600/610.
| Device ID | K153625 |
| 510k Number | K153625 |
| Device Name: | Single Use Injector NM600/610 |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170378154 | K153625 | 000 |
| 14953170377812 | K153625 | 000 |
| 14953170377799 | K153625 | 000 |
| 14953170377775 | K153625 | 000 |
| 14953170377751 | K153625 | 000 |
| 14953170377737 | K153625 | 000 |
| 14953170377713 | K153625 | 000 |
| 14953170377690 | K153625 | 000 |
| 14953170377676 | K153625 | 000 |
| 14953170377652 | K153625 | 000 |
| 14953170377638 | K153625 | 000 |
| 14953170377614 | K153625 | 000 |
| 14953170377591 | K153625 | 000 |
| 14953170377577 | K153625 | 000 |
| 14953170377836 | K153625 | 000 |
| 14953170377850 | K153625 | 000 |
| 14953170377874 | K153625 | 000 |
| 14953170378130 | K153625 | 000 |
| 14953170378116 | K153625 | 000 |
| 14953170378093 | K153625 | 000 |
| 14953170378079 | K153625 | 000 |
| 14953170378055 | K153625 | 000 |
| 14953170378031 | K153625 | 000 |
| 14953170378017 | K153625 | 000 |
| 14953170377997 | K153625 | 000 |
| 14953170377973 | K153625 | 000 |
| 14953170377959 | K153625 | 000 |
| 14953170377935 | K153625 | 000 |
| 14953170377911 | K153625 | 000 |
| 14953170377898 | K153625 | 000 |
| 14953170377553 | K153625 | 000 |