Smart Kit Basic, Smart Kit Pro— 510(k) K202443

Substantially Equivalent

Bsl Co., Ltd.

FDA 510(k) clearance K202443 for Smart Kit Basic, Smart Kit Pro, Substantially Equivalent on 2021-03-11. Applicant: Bsl Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bsl Co., Ltd.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2020-08-26
Decision date: 2021-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gimhae-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.