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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K020714
Device Name RUSCH FLONEIL; FLOCATH INTROGEL
Applicant
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number876.5130
Classification Product Code
GBM  
Date Received03/05/2002
Decision Date 07/01/2002
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
Predetermined Change
Control Plan Authorized		 No
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