K060971 is an FDA 510(k) clearance for the OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Omi Manufacturing Pty., Ltd. (Deer Field, US). The FDA issued a Cleared decision on October 24, 2006, 200 days after receiving the submission on April 7, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K060971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2006 |
| Decision Date | October 24, 2006 |
| Days to Decision | 200 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 |