510(k) K122837
K122837 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "AUTOJECT 2 FOR GLASSY SYRINGE". The FDA issued a decision of Substantially Equivalent on October 15, 2012. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Owen Mumford, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2012
- Date Received
- September 17, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Syringe Needle
- Device Class
- Class II
- Regulation Number
- 880.6920
- Review Panel
- HO
- Submission Type