K914608 is an FDA 510(k) clearance for the BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120, a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 9, 1992, 84 days after receiving the submission on October 17, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K914608 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 1991 |
| Decision Date | January 09, 1992 |
| Days to Decision | 84 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 |