K803292 is an FDA 510(k) clearance for the FIELD SUCTION DISSECTOR. This device is classified as a Dissector, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDI).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981, 30 days after receiving the submission on December 30, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K803292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1980 |
| Decision Date | January 29, 1981 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDI — Dissector, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |