K780887 is an FDA 510(k) clearance for the IMPROVED DISPOSABLE HYPODERMIC NEEDLE. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978, 27 days after receiving the submission on May 26, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K780887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1978 |
| Decision Date | June 22, 1978 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |