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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 K232625
Device Name Steriking® Pouch for Robotic Instruments
Applicant
Wipak OY
Wipaktie 2
Nastola,  FI FI-15560
Applicant Contact Hanna Marttila
Correspondent
Compliance Systems International, LLC
1083 Delaware Rd.
Buffalo,  NY  14209
Correspondent Contact Amanda Singleton
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/29/2023
Decision Date 06/07/2024
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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