K974741 is an FDA 510(k) clearance for the MANAN ACCURA NEEDLE, a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on January 8, 1998, 20 days after receiving the submission on December 19, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K974741 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 19, 1997 |
| Decision Date | January 08, 1998 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |