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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K192904
Device Name SpeediCath Compact Set
Applicant
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Michael Bumgarner
Correspondent
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Michael Bumgarner
Regulation Number876.5130
Classification Product Code
GBM  
Date Received10/15/2019
Decision Date 11/02/2020
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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