Smoklean— 510(k) K173108
Substantially EquivalentSejong Medical Co., Ltd.
FDA 510(k) clearance K173108 for Smoklean, Substantially Equivalent on 2018-05-18. Applicant: Sejong Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sejong Medical Co., Ltd.
- Product code
- Code FYD
- Device class
- Class 2
- Regulation
- 21 CFR 878.5070
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paju-Si, KR
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