REXLON, REXSIL
FDA 510(k) clearance K161633 · decided 2017-03-02
Clearance details
- K-number
- K161633
- Device name
- REXLON, REXSIL
- Applicant
- Sm Eng Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-13
- Decision date
- 2017-03-02
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- GAR
- Device class
- 2
- Regulation number
- 878.5020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sasang-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.