FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUREPAIR DURA REGENERATION MATRIX
K Number: K052211
·
Decision Sep 14, 2005
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
28
Review Days
30
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Basic Information
- Device Name
- DUREPAIR DURA REGENERATION MATRIX
- K Number
- K052211
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Neurosurgery
- Date Received
- August 15, 2005
- Decision Date
- September 14, 2005
- Product Code
- GXQ
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
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