The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Aspiration Needle Na-u200h.
| Device ID | K180449 |
| 510k Number | K180449 |
| Device Name: | Single Use Aspiration Needle NA-U200H |
| Classification | Biopsy Needle |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170402521 | K180449 | 000 |
| 14953170402507 | K180449 | 000 |
| 14953170380522 | K180449 | 000 |
| 14953170380485 | K180449 | 000 |
| 14953170380447 | K180449 | 000 |
| 14953170380409 | K180449 | 000 |