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FDA 510(k) Application Details - K102931
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K102931
Device Name
Endoscopic Tissue Approximation Device
Applicant
USGI MEDICAL
1140 CALLE CORDILLERA
SAN CLEMENTE, CA 92673 US
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Contact
MARY LOU MOONEY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCW
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More FDA Info for this Product Code
Date Received
10/04/2010
Decision Date
12/30/2010
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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