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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 K221401
Device Name Self-Cath and Self-Cath Plus
Applicant
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Preeti Jain
Correspondent
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Preeti Jain
Regulation Number876.5130
Classification Product Code
EZD  
Date Received05/16/2022
Decision Date 12/02/2022
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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