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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 K121457
Device Name SPEEDICATH COMPACT SET (12 FR)
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact BRIAN SCHMIDT
Correspondent
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact BRIAN SCHMIDT
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/16/2012
Decision Date 10/02/2012
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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