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FDA 510(k) Application Details - K162717
Device Classification Name
Prosthesis, Esophageal
More FDA Info for this Device
510(K) Number
K162717
Device Name
Prosthesis, Esophageal
Applicant
Cook Ireland Ltd.
O'Halloran Road, National Technology Park
Limerick IE
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Contact
Jane Kennedy
Other 510(k) Applications for this Contact
Regulation Number
878.3610
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Classification Product Code
ESW
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More FDA Info for this Product Code
Date Received
09/29/2016
Decision Date
12/21/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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