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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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