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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K173276
Device Name Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Claire Pigman
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Claire Pigman
Classification Product Code
FRO  
Date Received10/12/2017
Decision Date 07/02/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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