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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 K251419
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
Herschel J. Gaddy & Associates
1805 Oak Ridge Circle, Suite 101
St. Joseph,  MO  64506
Correspondent Contact Jennifer Prussman
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/07/2025
Decision Date 01/14/2026
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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