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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 K183335
Device Name Medline Poly-Cath Red Polymer Urethral Catheter
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Dinah Rincones
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Dinah Rincones
Regulation Number876.5130
Classification Product Code
GBM  
Date Received12/03/2018
Decision Date 06/12/2019
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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