510(k) K060971
K060971 is an FDA 510(k) premarket notification submitted by Omi Manufacturing Pty., Ltd. for the device "OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS". The FDA issued a decision of Substantially Equivalent on October 24, 2006. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Omi Manufacturing Pty., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2006
- Date Received
- April 7, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type