S-Line
FDA 510(k) clearance K182193 · decided 2019-01-22
Clearance details
- K-number
- K182193
- Device name
- S-Line
- Applicant
- Biocetec Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-14
- Decision date
- 2019-01-22
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- NJM
- Device class
- 2
- Regulation number
- 872.5470
- 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.