FDA 510(k) Application Details - K242622

Device Classification Name

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510(K) Number K242622
Device Name Sterile Lancets for Single Use
Applicant Ningbo Caremed Medical Products Co., Ltd.
No.79 Jiutang Road, Hangzhou Bay New Zone
Ningbo CN
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Contact Cen Wei
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Regulation Number

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Classification Product Code QRK
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Date Received 09/03/2024
Decision Date 10/28/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242622


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