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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K013345
Device Name INCARE INTERMITTENT CATHETER
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number876.5130
Classification Product Code
KOD  
Date Received10/09/2001
Decision Date 01/07/2002
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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