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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 K902710
Device Name FOLEY CATHETER
Applicant
Societa Gruppi Elastomeri S.A.
Via Stefano Franscini 24
6850 Mendrisio (Ch)
Mendrisio,  ES
Applicant Contact TOZZI FONTANA
Correspondent
Societa Gruppi Elastomeri S.A.
Via Stefano Franscini 24
6850 Mendrisio (Ch)
Mendrisio,  ES
Correspondent Contact TOZZI FONTANA
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/20/1990
Decision Date 11/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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