FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Collagen Dural Regeneration Matrix
K Number: K150825
·
Decision Nov 20, 2015
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
47
Review Days
238
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Basic Information
- Device Name
- Collagen Dural Regeneration Matrix
- K Number
- K150825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collagen Matrix, Inc.
- Date Received
- March 27, 2015
- Decision Date
- November 20, 2015
- 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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