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FDA 510(k) Application Details - K192183
Device Classification Name
Catheter, Ureteral, Gastro-Urology
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510(K) Number
K192183
Device Name
Catheter, Ureteral, Gastro-Urology
Applicant
Promepal Sam
9 Avenue Albert II
Monaco 98000 MC
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Contact
Mohamed Rekik
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Regulation Number
876.5130
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Classification Product Code
EYB
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Date Received
08/12/2019
Decision Date
04/23/2020
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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