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FDA 510(k) Application Details - K974637
Device Classification Name
Electrode, Electrosurgical, Active, Urological
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510(K) Number
K974637
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE, CA 95131 US
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ASHVIN DESAI
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Regulation Number
876.4300
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Classification Product Code
FAS
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More FDA Info for this Product Code
Date Received
12/12/1997
Decision Date
01/07/1998
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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