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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 K032710
Device Name CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
Applicant
Apogee Medical, Inc.
90 Weathers St.
Youngsville,  NC  27596
Applicant Contact DIANE N PEPER
Correspondent
Apogee Medical, Inc.
90 Weathers St.
Youngsville,  NC  27596
Correspondent Contact DIANE N PEPER
Regulation Number876.5130
Classification Product Code
KOD  
Date Received09/02/2003
Decision Date 01/09/2004
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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