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FDA 510(k) Application Details - K072094
Device Classification Name
Prosthesis, Esophageal
More FDA Info for this Device
510(K) Number
K072094
Device Name
Prosthesis, Esophageal
Applicant
M.I. TECH CO., LTD.
P.O. BOX 2007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
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
07/30/2007
Decision Date
09/25/2008
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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