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FDA 510(k) Application Details - K222224
Device Classification Name
Lancet, Blood
More FDA Info for this Device
510(K) Number
K222224
Device Name
Lancet, Blood
Applicant
MediPurpose Pte. Ltd.
10 Anson Road, No. 12-08 International Plaza
Singapore 079903 SG
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Contact
Adeline Yi
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
FMK
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More FDA Info for this Product Code
Date Received
07/25/2022
Decision Date
09/22/2022
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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