The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use Aspiration Needle Na-201sx-4022.
| Device ID | K050503 |
| 510k Number | K050503 |
| Device Name: | SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 |
| Classification | Biopsy Needle |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Larua Storms-tyler |
| Correspondent | Larua Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-05-12 |
| Summary: | summary |