510(k) K070759
K070759 is an FDA 510(k) premarket notification submitted by Vidacare Corporation for the device "POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 2007. The device falls under product code FCF (Instrument, Biopsy, Mechanical, Gastrointestinal), a Class II device regulated under 21 CFR 876.1075. Vidacare Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2007
- Date Received
- March 20, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Mechanical, Gastrointestinal
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type