The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for Illinois Sternum/iliac Aspiration Needle.
| Device ID | K843690 |
| 510k Number | K843690 |
| Device Name: | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
| Contact | Robert A Popper |
| Correspondent | Robert A Popper POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-19 |
| Decision Date | 1984-10-25 |