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510(k) K202443

Smart Kit Basic, Smart Kit Pro by Bsl Co., Ltd. — Product Code MUU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2021
Date Received
August 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).

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