K063755 is an FDA 510(k) clearance for the PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on February 27, 2007, 70 days after receiving the submission on December 19, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K063755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2006 |
| Decision Date | February 27, 2007 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG — Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |