The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Aspiration Needle Na-u201h.
Device ID | K181994 |
510k Number | K181994 |
Device Name: | Single Use Aspiration Needle NA-U201H |
Classification | Biopsy Needle |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-26 |
Decision Date | 2018-10-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170402644 | K181994 | 000 |
14953170402620 | K181994 | 000 |
14953170402606 | K181994 | 000 |
14953170402583 | K181994 | 000 |
14953170402569 | K181994 | 000 |
14953170402545 | K181994 | 000 |