FDA 510(k) Application Details - K222472

Device Classification Name

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510(K) Number K222472
Device Name Lancing System, Sterile Lancet for Single Use, Lancing Device
Applicant Shandong Lianfa Medical Plastic Products Co. Ltd.
No. 1 Shuangshan Sanjian Road, Zhangqiu
Jinan 250200 CN
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Contact Charles Shen
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Regulation Number

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Classification Product Code QRL
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Date Received 08/16/2022
Decision Date 11/30/2022
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



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