K122837 is an FDA 510(k) clearance for the AUTOJECT 2 FOR GLASSY SYRINGE. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Owen Mumford, Ltd. (Woodstock, Oxfordshire, GB). The FDA issued a Cleared decision on October 15, 2012, 28 days after receiving the submission on September 17, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K122837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2012 |
| Decision Date | October 15, 2012 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH - Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |