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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 K013174
Device Name PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
Applicant
Porges S.A.
Usine Du Pontet Bp 89
Sarlat,  FR 24203
Applicant Contact BERNARD ISMAEL
Correspondent
Porges S.A.
Usine Du Pontet Bp 89
Sarlat,  FR 24203
Correspondent Contact BERNARD ISMAEL
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/24/2001
Decision Date 01/04/2002
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
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