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FDA 510(k) Application Details - K242622
Device Classification Name
More FDA Info for this Device
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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More FDA Info for this Product Code
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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