K981089 is an FDA 510(k) clearance for the TISSOMAT AND SPRAY SET. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on July 5, 2000, 833 days after receiving the submission on March 25, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K981089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1998 |
| Decision Date | July 05, 2000 |
| Days to Decision | 833 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |