FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Flap Fixator, Burr Hole Cover
K Number: K192310
·
Decision Jun 3, 2020
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
1
Review Days
282
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Basic Information
- Device Name
- Flap Fixator, Burr Hole Cover
- K Number
- K192310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ossaware Biotech Co., Ltd.
- Date Received
- August 26, 2019
- Decision Date
- June 3, 2020
- Product Code
- GXR
- 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 |
|---|---|---|---|
| GXR | Cover, Burr Hole | FDA class 2 | Neurology |
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