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FDA 510(k) Application Details - K090851
Device Classification Name
Endoscope Channel Accessory
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510(K) Number
K090851
Device Name
Endoscope Channel Accessory
Applicant
BYRNE MEDICAL INC.
3150 POLLOK DR
CONROE, TX 77303 US
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Contact
JENNIFER JAMES
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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
03/30/2009
Decision Date
07/02/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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