510(k) K121181
K121181 is an FDA 510(k) premarket notification submitted by Alliance Partners, LLC for the device "SWANNSHIDI BONE MARROW ASPIRATION NEEDLE". The FDA issued a decision of Substantially Equivalent on August 22, 2012. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Alliance Partners, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2012
- Date Received
- April 18, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type