
Owens & Minor (O&M) Halyard, Inc.
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Halyard ONE-STEP* Sterilization Wrap is an FDA 510(k)-cleared medical device (K192147) manufactured by Owens & Minor (O&M) Halyard, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2019. Regulation: 8.

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