The following data is part of a premarket notification filed by Radiation Development Co., Inc. with the FDA for Lee Aspiration Needle.
| Device ID | K771574 |
| 510k Number | K771574 |
| Device Name: | LEE ASPIRATION NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | RADIATION DEVELOPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-15 |
| Decision Date | 1977-12-06 |