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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 K210810
Device Name Steiking Packaging for Medical Devices
Applicant
Wipak OY
Wipaktie 2
Nastola,  FI FI-15560
Applicant Contact Mira Santala
Correspondent
Compliance Systems International, LLC
7 Windham Hill
Mendon,  NY  14056
Correspondent Contact Steven T. Singleton
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/17/2021
Decision Date 01/23/2022
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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