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510(k) K240330

HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) by O&M Halyard, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2024
Date Received
February 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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