K091279 is an FDA 510(k) clearance for the NIPRO DISPOSABLE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on August 12, 2009, 103 days after receiving the submission on May 1, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K091279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2009 |
| Decision Date | August 12, 2009 |
| Days to Decision | 103 days |
| Submission Type | Special |
| 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 |