K771209 is an FDA 510(k) clearance for the TERUFUSION BLOOD ADMIN. SET. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1977, 21 days after receiving the submission on July 5, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K771209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1977 |
| Decision Date | July 26, 1977 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |