K070856 is an FDA 510(k) clearance for the ICU MEDICAL SINGLE-USE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 5, 2007, 191 days after receiving the submission on March 28, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K070856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2007 |
| Decision Date | October 05, 2007 |
| Days to Decision | 191 days |
| Submission Type | Abbreviated |
| 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 |