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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 K203177
Device Name Sterisystem Dry-Base Instrument Tray
Applicant
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Applicant Contact Steven Dowdley
Correspondent
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Correspondent Contact Steven Dowdley
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/26/2020
Decision Date 01/02/2022
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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