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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K241210
Device Name Luja Coude
Applicant
Coloplast Corp
1601 West River Road North
Plymouth,  MN  55411
Applicant Contact Troy Thome
Correspondent
Coloplast Corp
1601 West River Road North
Plymouth,  MN  55411
Correspondent Contact Troy Thome
Regulation Number876.5130
Classification Product Code
EZD  
Date Received04/30/2024
Decision Date 11/21/2024
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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