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FDA 510(k) Application Details - K110088
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K110088
Device Name
Endoscope Channel Accessory
Applicant
BYRNE MEDICAL INCORPORATED
3150 Pollok Drive
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
01/12/2011
Decision Date
06/10/2011
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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