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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 K183701
Device Name Stryker ChestShield Sterilization Tray System
Applicant
Paragon Medical
8 Matchett Dr.
Pierceton,  IN  46562
Applicant Contact Rebecca Walker
Correspondent
Paragon Medical
8 Matchett Dr.
Pierceton,  IN  46562
Correspondent Contact Rebecca Walker
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/31/2018
Decision Date 05/07/2019
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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