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FDA 510(k) Application Details - K150852
Device Classification Name
More FDA Info for this Device
510(K) Number
K150852
Device Name
SIC 8000
Applicant
COSMO TECHNOLOGIES, LTD.
42-43 AMIENS STREET
DUBLIN 1 IE
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Contact
RICHARD JONES
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Regulation Number
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Classification Product Code
PLL
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Date Received
03/31/2015
Decision Date
09/03/2015
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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