The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Retrieval Nitinol Basket V.
Device ID | K170811 |
510k Number | K170811 |
Device Name: | Single Use Retrieval Nitinol Basket V |
Classification | Dislodger, Stone, Biliary |
Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji, 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 | LQR |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-17 |
Decision Date | 2017-11-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170395328 | K170811 | 000 |