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510(k) K243001

Device
Sterile Water USP and Sterile 0.9% Normal Saline USP
Applicant
Laboratorios Biogalenic S.A. DE C.V.
510(k) number
K243001
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-06
Date received
2024-09-26
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Roberto Quiñonez
Address
Calle Claper, Blvd. Del Ejercito Nacional Km 5.5, Soyapango, San Salvador SV 1639 1639

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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