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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K150550
Device Name SilverCoat Silicone Foley Catheter
Applicant
Covalontechnologies, Inc.
405 Britannia Rd. E.
Suite 106
Mississauga,  CA L4Z 3E6
Applicant Contact Kim Crooks
Correspondent
Covalontechnologies, Inc.
405 Britannia Rd. E.
Suite 106
Mississauga,  CA L4Z 3E6
Correspondent Contact Kim Crooks
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/03/2015
Decision Date 11/24/2015
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 Yes
Predetermined Change
Control Plan Authorized		 No
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