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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 K200142
Device Name SpeediCath Soft
Applicant
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Delaney McDougal
Correspondent
Coloplast
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Delaney McDougal
Regulation Number876.5130
Classification Product Code
GBM  
Date Received01/22/2020
Decision Date 07/30/2020
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
Predetermined Change
Control Plan Authorized		 No
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