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FDA 510(k) Application Details - K122270
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K122270
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN, TX 78746 US
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Contact
HEATHER CRAWFORD, RAC
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Regulation Number
876.1500
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Classification Product Code
FED
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More FDA Info for this Product Code
Date Received
07/30/2012
Decision Date
09/28/2012
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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