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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K180915
Device Name Sonicision Reusable Sterilization Tray
Applicant
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Candice Bautista-Biddle
Correspondent
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Candice Bautista-Biddle
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/09/2018
Decision Date 07/17/2018
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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