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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 K231999
Device Name Steriking® LT-Blueline Pouches with Tyvek®
Applicant
Wipak OY
Wipaktie 2
Nastola,  FI FI-15560
Applicant Contact Hanna Marttila
Correspondent
Compliance Systems International, LLC
39 Lockhart Circle
Amherst,  NY  14228
Correspondent Contact Amanda Singleton
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/05/2023
Decision Date 09/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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