K033589 is an FDA 510(k) clearance for the BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on October 4, 2004, 326 days after receiving the submission on November 13, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K033589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2003 |
| Decision Date | October 04, 2004 |
| Days to Decision | 326 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 |