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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K021856
Device Name PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
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
EYB  
Date Received06/06/2002
Decision Date 10/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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