K771203 is an FDA 510(k) clearance for the DISP. HYPODERMIC NEEDLE. 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 14, 1977, 9 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 | K771203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1977 |
| Decision Date | July 14, 1977 |
| Days to Decision | 9 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 |