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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
510(k) Number K233526
Device Name Medline Open-back Level 3 Protective Gown
Applicant
Medline Industries, LP
1 Three Lakes Dr.
Northfield,  IL  60093
Applicant Contact Kelsey Closen
Correspondent
Medline Industries, LP
1 Three Lakes Dr.
Northfield,  IL  60093
Correspondent Contact Kelsey Closen
Regulation Number878.4040
Classification Product Code
QPC  
Date Received11/01/2023
Decision Date 03/05/2024
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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