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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 K123675
Device Name RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Applicant Contact BRIAN SCHMIDT
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.1500
Classification Product Code
FED  
Date Received11/30/2012
Decision Date 03/01/2013
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
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