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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 K253454
Device Name HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
Applicant
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Applicant Contact Anureet Singh
Correspondent
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Correspondent Contact Anureet Singh
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/03/2025
Decision Date 05/18/2026
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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