K864778 is an FDA 510(k) clearance for the MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Mac Lee Medical Products (Topeka, US). The FDA issued a Cleared decision on December 29, 1986, 21 days after receiving the submission on December 8, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K864778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1986 |
| Decision Date | December 29, 1986 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |