The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Disposable Aspiration Needle Na-200h.
| Device ID | K023272 |
| 510k Number | K023272 |
| Device Name: | DISPOSABLE ASPIRATION NEEDLE NA-200H |
| Classification | Biopsy Needle |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170309233 | K023272 | 000 |
| 14953170169974 | K023272 | 000 |
| 14953170309097 | K023272 | 000 |
| 14953170309110 | K023272 | 000 |
| 14953170309134 | K023272 | 000 |
| 14953170309158 | K023272 | 000 |
| 14953170309172 | K023272 | 000 |
| 14953170309196 | K023272 | 000 |
| 14953170309219 | K023272 | 000 |
| 14953170169967 | K023272 | 000 |