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510(k) K252941

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops by O&M Halyard, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2025
Date Received
September 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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Other clearances for product code FXX

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