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FDA 510(k) Application Details - K983765
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K983765
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE, CA 95131 US
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Contact
ASHVIN DESAI
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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
10/26/1998
Decision Date
12/11/1998
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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