IBS Implant System II
FDA 510(k) clearance K200753 · decided 2020-06-09
Clearance details
- K-number
- K200753
- Device name
- IBS Implant System II
- Applicant
- Innobiosurg Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-23
- Decision date
- 2020-06-09
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Daejeon, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.