510(k) K072320
K072320 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "GREINER VACUETTE QUICKSHIELD COMPLETE". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Greiner Bio-One North America, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2007
- Date Received
- August 20, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type