FDA 510(k) Application Details - K241848

Device Classification Name Lancet, Blood

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510(K) Number K241848
Device Name Lancet, Blood
Applicant Ningbo Caremed Medical Products Co. Ltd.
No.79 Jiutang Road, South Side Hangzhou Bay New Zone
Ningbo 315336 CN
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Contact Wei Chen
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Regulation Number 878.4800

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Classification Product Code FMK
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Date Received 06/27/2024
Decision Date 08/20/2024
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 K241848


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