The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Olympus Urf-v2/v2r.
Device ID | K172246 |
510k Number | K172246 |
Device Name: | OLYMPUS URF-V2/V2R |
Classification | Ureteroscope And Accessories, Flexible/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 | FGB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-26 |
Decision Date | 2018-03-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170343612 | K172246 | 000 |
04953170343582 | K172246 | 000 |