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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 K190950
Device Name Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Pauline Maralit
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Pauline Maralit
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/11/2019
Decision Date 07/04/2019
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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