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510(k) K243001

Sterile Water USP and Sterile 0.9% Normal Saline USP by Laboratorios Biogalenic S.A. DE C.V. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2025
Date Received
September 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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