FDA 510(k) Application Details - K041995

Device Classification Name Catheter, Nephrostomy, General & Plastic Surgery

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510(K) Number K041995
Device Name Catheter, Nephrostomy, General & Plastic Surgery
Applicant URESIL, LLC
5418 W. TOUHY AVE.
SKOKIE, IL 60077 US
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Contact MATTHEW MAHON
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Regulation Number 878.4200

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Classification Product Code GBO
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Date Received 07/23/2004
Decision Date 08/19/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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