The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Rhino-laryngo Fiberscope Olympus Enf-gp2.
| Device ID | K181240 |
| 510k Number | K181240 |
| Device Name: | Rhino-Laryngo Fiberscope Olympus ENF-GP2 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-10 |
| Decision Date | 2018-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170399282 | K181240 | 000 |
| 04953170411328 | K181240 | 000 |