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FDA 510(k) Application Details - K013712
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K013712
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
ENTERIC MEDICAL TECHNOLOGIES
551 FOSTER CITY BLVD.
SUITE G
FOSTER CITY, CA 94404 US
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Contact
JILL M VISOR
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Regulation Number
876.1500
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Classification Product Code
FBK
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More FDA Info for this Product Code
Date Received
11/08/2001
Decision Date
05/31/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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