K913992 is an FDA 510(k) clearance for the ASPIRATION/INJECTION NEEDLE. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on October 30, 1991, 55 days after receiving the submission on September 5, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K913992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |