FDA 510(k) Application Details - K242316

Device Classification Name Lancet, Blood

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510(K) Number K242316
Device Name Lancet, Blood
Applicant Ningbo Medsun Medical Co., Ltd.
No. 298 Huangjipu Road, Jiangbei
Ningbo 315031 CN
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Contact Ping Liu
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Regulation Number 878.4800

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Classification Product Code FMK
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Date Received 08/05/2024
Decision Date 08/28/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242316


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