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FDA 510(k) Application Details - K102409
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K102409
Device Name
Endoscope Channel Accessory
Applicant
BYRNE MEDICAL INC.
3150 POLLOK DR
CONROE, TX 77303 US
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Contact
JOHN WILLIS
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Regulation Number
876.1500
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Classification Product Code
ODC
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More FDA Info for this Product Code
Date Received
08/24/2010
Decision Date
11/04/2010
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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