K061092 is an FDA 510(k) clearance for the BAXTER DUPLOSPRAY MIS APPLICATOR. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 13, 2006, 147 days after receiving the submission on April 19, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K061092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2006 |
| Decision Date | September 13, 2006 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |