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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K172954
Device Name Medline Prevention CoolZone Gown
Applicant
Medline Industries, Inc.
3 Lakes Dr.
Northfield,  IL  60093
Applicant Contact Pauline Maralit
Correspondent
Medline Industries, Inc.
3 Lakes Dr.
Northfield,  IL  60093
Correspondent Contact Pauline Maralit
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/26/2017
Decision Date 06/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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