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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K173348
Device Name 0.9% Sodium Chloride Injection, USP
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Matt Clausen
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Matt Clausen
Regulation Number880.5200
Classification Product Code
NGT  
Date Received10/25/2017
Decision Date 06/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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