HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

Wrap, Sterilization

Owens & Minor (O&M) Halyard, Inc.

The following data is part of a premarket notification filed by Owens & Minor (o&m) Halyard, Inc. with the FDA for Halyard One-step Sterilization Wrap, Halyard Quick Check Sterilization Wrap.

Pre-market Notification Details

Device IDK214007
510k NumberK214007
Device Name:HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
ClassificationWrap, Sterilization
Applicant Owens & Minor (O&M) Halyard, Inc. 9120 Lockwood Blvd Mechanicsville,  VA  23116
ContactAnureet Singh
CorrespondentAnureet Singh
Owens & Minor (O&M) Halyard, Inc. 9120 Lockwood Blvd Mechanicsville,  VA  23116
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-22
Decision Date2022-07-27

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