510(k) K022712
K022712 is an FDA 510(k) premarket notification submitted by Medical Design, LLC for the device "HAND DRILL, MODEL 11-9901-7". The FDA issued a decision of Substantially Equivalent on November 12, 2002. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Medical Design, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2002
- Date Received
- August 14, 2002
- 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