Neo GBR System
FDA 510(k) clearance K160991 · decided 2017-01-10
Clearance details
- K-number
- K160991
- Device name
- Neo GBR System
- Applicant
- Neobiotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-08
- Decision date
- 2017-01-10
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- DZL
- Device class
- 2
- Regulation number
- 872.4880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.