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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K243001
Device Name Sterile Water USP and Sterile 0.9% Normal Saline USP
Applicant
Laboratorios Biogalenic S.A. DE C.V,
Calle Claper, Blvd. Del Ejercito Nacional km 5.5,
Soyapango,
San Salvador,  SV 1639
Applicant Contact Roberto Quiñonez
Correspondent
Liberty Management Group Ltd.
75 Executive Dr, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Classification Product Code
FRO  
Date Received09/26/2024
Decision Date 03/06/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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