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FDA 510(k) Application Details - K133359
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K133359
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
ENDO-AID, INC.
1835 MARKET STREET, 29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2013
Decision Date
02/11/2014
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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