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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K061324
Device Name EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
Applicant
Rtc Inc.-Memcath Technologies, LLC
1777 Oakdale Ave.,
West St. Paul,  MN  55118
Applicant Contact MARC JAKER
Correspondent
Rtc Inc.-Memcath Technologies, LLC
1777 Oakdale Ave.,
West St. Paul,  MN  55118
Correspondent Contact MARC JAKER
Regulation Number876.1500
Classification Product Code
FED  
Date Received05/11/2006
Decision Date 06/20/2006
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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