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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 K233101
Device Name Luja Coude (20108 Male CH18 - large packaging)
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Troy Thome
Correspondent
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Troy Thome
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
GBM  
Date Received09/26/2023
Decision Date 10/26/2023
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
Predetermined Change
Control Plan Authorized		 No
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