The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Sterile, Disposable, Hypodermic Needles.
| Device ID | K830378 |
| 510k Number | K830378 |
| Device Name: | STERILE, DISPOSABLE, HYPODERMIC NEEDLES |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-04 |
| Decision Date | 1983-03-24 |