FDA 510(k) Application Details - K023808

Device Classification Name System, Irrigation, Urological

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510(K) Number K023808
Device Name System, Irrigation, Urological
Applicant INTERNATIONAL MEDSURG CONNECTION
P.O. BOX 848
GRAYSLAKE, IL 60030 US
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Contact MICHELE H VOVOLKA
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Regulation Number 000.0000

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Classification Product Code LJH
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Date Received 11/14/2002
Decision Date 03/10/2003
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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