K060095 is an FDA 510(k) clearance for the MODIFICATION TO: VACLOK SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on February 10, 2006, 28 days after receiving the submission on January 13, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K060095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2006 |
| Decision Date | February 10, 2006 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |