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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 K234050
Device Name HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
Applicant
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Anureet Singh
Correspondent
O&M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Correspondent Contact Anureet Singh
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/21/2023
Decision Date 09/16/2024
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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