K830386 is an FDA 510(k) clearance for the DAVOL SURGICAL SUCTION IRRIGATION INSTR. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983, 53 days after receiving the submission on February 4, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K830386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1983 |
| Decision Date | March 29, 1983 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |