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FDA 510(k) Application Details - K033954
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
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510(K) Number
K033954
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
USGI MEDICAL, INC.
1140 CALLE CORDILLERA
SAN CLEMENTE, CA 92673 US
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Contact
JEFFREY A ANDERSON
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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
12/22/2003
Decision Date
03/19/2004
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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