FDA 510(k) Application Details - K232330

Device Classification Name

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510(K) Number K232330
Device Name Lancing System
Applicant Ningbo Medsun Medical Co., Ltd.
No.55 Jinxi Road, Zhenhai
Ningbo 315221 CN
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Contact Liu Ping
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Regulation Number

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Classification Product Code QRK
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Date Received 08/03/2023
Decision Date 01/04/2024
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 K232330


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