K880377 is an FDA 510(k) clearance for the NOVO VIVO MODEL #17140 AND #17135. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Genesis Industries, Inc. (Spring Valley, US). The FDA issued a Cleared decision on April 4, 1988, 68 days after receiving the submission on January 27, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K880377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1988 |
| Decision Date | April 04, 1988 |
| Days to Decision | 68 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 |