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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 K173615
Device Name Stryker Universal Select Sterilization Tray System
Applicant
Paragon Medical
8 Matchett Dr.
Pierceton,  IN  46562
Applicant Contact Rebecca Walker
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number880.6850
Classification Product Code
KCT  
Date Received11/22/2017
Decision Date 04/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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