FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRONTIER DEVICES NEURO SYSTEM
K Number: K100205
·
Decision Dec 13, 2010
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
1
Review Days
322
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Basic Information
- Device Name
- FRONTIER DEVICES NEURO SYSTEM
- K Number
- K100205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Folsom Metal Products, Inc.
- Date Received
- January 25, 2010
- Decision Date
- December 13, 2010
- Product Code
- GWO
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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