The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Na Needles.
| Device ID | K904667 |
| 510k Number | K904667 |
| Device Name: | NA NEEDLES |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | J Dillon |
| Correspondent | J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-15 |
| Decision Date | 1990-12-12 |