FDA 510(k) Application Details - K202443

Device Classification Name System, Suction, Lipoplasty

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510(K) Number K202443
Device Name System, Suction, Lipoplasty
Applicant BSL Co., Ltd
6-13, Chilsan-ro 237beon-gil
Gimhae-si KR
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Contact Jun Seok Lee
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Regulation Number 878.5040

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Classification Product Code MUU
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Date Received 08/26/2020
Decision Date 03/11/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K202443


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