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FDA 510(k) Application Details - K182403
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
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510(K) Number
K182403
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Johnathan Liu
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Regulation Number
876.1500
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Classification Product Code
FED
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More FDA Info for this Product Code
Date Received
09/04/2018
Decision Date
05/29/2019
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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