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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K073507
Device Name ANCHORAGE ACCESS KIT
Applicant
Epitek, Inc.
4801 W. 81st St.
Suite 105
Bloomington,  MN  55437
Applicant Contact WERNER HAMPL
Correspondent
Epitek, Inc.
4801 W. 81st St.
Suite 105
Bloomington,  MN  55437
Correspondent Contact WERNER HAMPL
Regulation Number876.1500
Classification Product Code
ODC  
Date Received12/13/2007
Decision Date 03/05/2008
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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