510(k) K875018
K875018 is an FDA 510(k) premarket notification submitted by Neurodynamics, Inc. for the device "GHAJAR GUIDE TWIST DRILL". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Neurodynamics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1988
- Date Received
- December 4, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Manual)
- Device Class
- Class II
- Regulation Number
- 882.4300
- Review Panel
- NE
- Submission Type