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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 K180258
Device Name SpeediCath Standard
Applicant
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Ngoc Linh Pham Latchman
Correspondent
Coloplast
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Troy Thome
Regulation Number876.5130
Classification Product Code
GBM  
Date Received01/30/2018
Decision Date 10/25/2018
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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