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FDA 510(k) Application Details - K220434
Device Classification Name
More FDA Info for this Device
510(K) Number
K220434
Device Name
Blue Eye (TS-905)
Applicant
The Standard Co., Ltd.
120, Gunpocheomdansaneop 2-ro
Gunpo-si 15880 KR
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Contact
Sung Nam Kim
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Regulation Number
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Classification Product Code
PLL
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Date Received
02/15/2022
Decision Date
08/12/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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