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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 K131170
Device Name SONICISION STERILIZATION TRAY
Applicant
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact DAVID HORTON
Correspondent
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact DAVID HORTON
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/24/2013
Decision Date 08/28/2013
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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