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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 K140523
Device Name RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Applicant Contact BRIAN SCHMIDT
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.1500
Classification Product Code
FED  
Date Received03/04/2014
Decision Date 07/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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