510(k) K062711
K062711 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "ULTRA LOW PROFILE RONGEUR". The FDA issued a decision of Substantially Equivalent on March 7, 2007. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Baxano, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2007
- Date Received
- September 11, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type