FDA 510(k) Application Details - K021632

Device Classification Name Catheter, Nephrostomy, General & Plastic Surgery

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510(K) Number K021632
Device Name Catheter, Nephrostomy, General & Plastic Surgery
Applicant URESIL, L.P.
5418 WEST TOUHY AVE.
SKOKIE, IL 60077 US
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Contact CHARLES P GILL
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Regulation Number 878.4200

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Classification Product Code GBO
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Date Received 05/17/2002
Decision Date 06/13/2002
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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