K945225 is an FDA 510(k) clearance for the DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Myco Medical Supplies, Inc. (Raleigh, US). The FDA issued a Cleared decision on January 26, 1995, 92 days after receiving the submission on October 26, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K945225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1994 |
| Decision Date | January 26, 1995 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |