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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K242717
Device Name Laboratorios Biogalenic Sterile Water for Inhalation, 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
Laboratorios Biogalenic, S.A. DE C.V.
Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango
San Salvador,  SV 1639
Correspondent Contact Roberto Quiñonez
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/10/2024
Decision Date 01/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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