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FDA 510(k) Application Details - K180028
Device Classification Name
Dilator, Catheter, Ureteral
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510(K) Number
K180028
Device Name
Dilator, Catheter, Ureteral
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Carly Powell
Other 510(k) Applications for this Contact
Regulation Number
876.5470
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Classification Product Code
EZN
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More FDA Info for this Product Code
Date Received
01/03/2018
Decision Date
05/02/2018
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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