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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K013172
Device Name PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
Applicant
Porges S.A.
Centre D'Affaires
La Boursidiere
Le Plessis Robinson Cedex,  FR 92357
Applicant Contact BERNARD ISMAEL
Correspondent
Porges S.A.
Centre D'Affaires
La Boursidiere
Le Plessis Robinson Cedex,  FR 92357
Correspondent Contact BERNARD ISMAEL
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/24/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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