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FDA 510(k) Application Details - K093537
Device Classification Name
Prosthesis, Esophageal
More FDA Info for this Device
510(K) Number
K093537
Device Name
Prosthesis, Esophageal
Applicant
M.I. TECH CO., LTD.
49 CANDLEWOOD WAY
BUENA PARK, CA 90621 US
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Contact
BRANDON CHOI
Other 510(k) Applications for this Contact
Regulation Number
878.3610
More FDA Info for this Regulation Number
Classification Product Code
ESW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/16/2009
Decision Date
06/04/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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