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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 K242049
Device Name SureCath Set
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Minneapolis,  MN  55441
Applicant Contact Vallabha Tantry
Correspondent
Coloplast Corp.
1601 W. River Rd. N.
Minneapolis,  MN  55441
Correspondent Contact Vallabha Tantry
Regulation Number876.5130
Classification Product Code
EZD  
Date Received07/12/2024
Decision Date 11/26/2024
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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