FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
K Number: K130497
·
Decision Mar 29, 2013
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
4
Review Days
31
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Basic Information
- Device Name
- D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
- K Number
- K130497
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Corporation D/B/A Conmed Linvatec
- Date Received
- February 26, 2013
- Decision Date
- March 29, 2013
- 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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