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FDA 510(k) Application Details - K103155
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K103155
Device Name
Endoscope Channel Accessory
Applicant
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN, TX 78746 US
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Contact
GREG MATHISON
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/2010
Decision Date
10/28/2011
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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