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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Catheter, Urinary (Exludes Hiv Testing)
510(k) Number K071496
Device Name ICATH, STERILESURE
Applicant
Colorado Catheter Company, Inc.
15975 Winding Trail Rd.
Colorado Springs,  CO  80908
Applicant Contact DOUG WILSON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.5130
Classification Product Code
NWO  
Subsequent Product Code
EZD  
Date Received05/31/2007
Decision Date 08/15/2007
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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