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FDA 510(k) Application Details - K213232
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K213232
Device Name
Instrument, Biopsy
Applicant
Argon Medical Devices
1445 Flat Creek Road
Athens, TX 75751 US
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Contact
Daniel Lanois
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
09/30/2021
Decision Date
07/01/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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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