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FDA 510(k) Application Details - K181712
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K181712
Device Name
Endoscope Channel Accessory
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47402 US
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Contact
James O. Ebot Rnaw
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Regulation Number
876.1500
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Classification Product Code
ODC
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More FDA Info for this Product Code
Date Received
06/28/2018
Decision Date
07/26/2018
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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