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FDA 510(k) Application Details - K010122
Device Classification Name
System, Irrigation, Urological
More FDA Info for this Device
510(K) Number
K010122
Device Name
System, Irrigation, Urological
Applicant
G.U.-TEK
904 OAK TREE AVE.
SOUTH PLAINFIELD, NJ 07080 US
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Contact
ANTHONY SOLAZZO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LJH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/2001
Decision Date
06/04/2001
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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