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FDA 510(k) Application Details - K112576
Device Classification Name
Pump, Air, Non-Manual, For Endoscope
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510(K) Number
K112576
Device Name
Pump, Air, Non-Manual, For Endoscope
Applicant
ENDOCHOICE, INC.
11810 WILLS ROAD
SUITE 100
ALPHARETTA, GA 30009 US
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Contact
THERON GOBER
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Regulation Number
876.1500
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Classification Product Code
FEQ
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More FDA Info for this Product Code
Date Received
09/06/2011
Decision Date
01/25/2012
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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