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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 K191378
Device Name 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
Applicant
Medline Industries, Inc.
Three Lake Dr.
Northfiled,  IL  60093
Applicant Contact Stephanie Augsburg
Correspondent
Medline Industries, Inc.
Three Lake Dr.
Northfiled,  IL  60093
Correspondent Contact Stephanie Augsburg
Regulation Number880.5200
Classification Product Code
NGT  
Date Received05/23/2019
Decision Date 09/15/2019
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
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