510(k) K000482
K000482 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "MODIFICATION TO AUTOJECT MINI". The FDA issued a decision of Substantially Equivalent on March 6, 2000. 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
- March 6, 2000
- Date Received
- February 14, 2000
- Clearance Type
- Traditional
- 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