FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Neo GBR System
K Number: K160991
·
Decision Jan 10, 2017
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
17
Review Days
277
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Basic Information
- Device Name
- Neo GBR System
- K Number
- K160991
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neobiotech Co., Ltd.
- Date Received
- April 8, 2016
- Decision Date
- January 10, 2017
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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