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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 K220333
Device Name Medline Orbis LVL 3 Surgical Gown
Applicant
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Adam Ostrower
Correspondent
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Adam Ostrower
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/04/2022
Decision Date 05/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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