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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K192147
Device Name Halyard ONE-STEP* Sterilization Wrap
Applicant
Owens & Minor (O&M) Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Steven Dowdley
Correspondent
Peter R Kalkbrenner Sterilucent, Inc.
Minneapolis,  MN  55413
Correspondent Contact Peter Kalkbrenner
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/08/2019
Decision Date 10/10/2019
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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