FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROPOWER HAND PIECE HIGH SPEED DRILL
K Number: K060260
·
Decision Apr 10, 2006
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
93
Review Days
68
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Basic Information
- Device Name
- MICROPOWER HAND PIECE HIGH SPEED DRILL
- K Number
- K060260
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Corp.
- Date Received
- February 1, 2006
- Decision Date
- April 10, 2006
- Product Code
- HBC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBC | Motor, Drill, Electric | FDA class 2 | Neurology |
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