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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K234132
Device Name Medline Reusable Sterilization Wrappers
Applicant
Medline Industries, LP
1 Three Lakes Dr.
Northfield,  IL  60093
Applicant Contact Closen Kelsey
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Kelsey Closen
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/28/2023
Decision Date 09/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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