510(k) K935861
K935861 is an FDA 510(k) premarket notification submitted by Mednext, Inc. for the device "MEDNEXT BUR". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Mednext, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1994
- Date Received
- December 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type