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FDA 510(k) Application Details - K230310
Device Classification Name
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510(K) Number
K230310
Device Name
STAT Medical Device Lancing System
Applicant
STAT Medical Devices
2056 N.E. 153rd Street
North Miami Beach, FL 33162 US
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Contact
Hemel Mariano
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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
02/03/2023
Decision Date
09/08/2023
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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