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510(k) K243342

KP Protective Face Mask by Kp Trading Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
October 25, 2024
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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