K935505 is an FDA 510(k) clearance for the WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Kawasumi Laboratories Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on February 3, 1994, 79 days after receiving the submission on November 16, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K935505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1993 |
| Decision Date | February 03, 1994 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |