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FDA 510(k) Application Details - K220643
Device Classification Name
Lancet, Blood
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510(K) Number
K220643
Device Name
Lancet, Blood
Applicant
HTL-Strefa S.A.
Adamowek 7
Ozorkow 95-035 PL
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Contact
Justyna Zemigala
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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
03/04/2022
Decision Date
07/08/2022
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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