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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 K221377
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
53 Assembly Dr., Unit 149
Mendon,  NY  14506
Correspondent Contact Amanda Singleton
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/12/2022
Decision Date 12/22/2022
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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