510(k) K100958
K100958 is an FDA 510(k) premarket notification submitted by Baxano, Inc. for the device "MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 23, 2010. 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
- July 23, 2010
- Date Received
- April 7, 2010
- Clearance Type
- Special
- 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