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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K901114
Device Name MEDISONIC HUMDIFIER/INHALER
Applicant
Medisonic U.S.A., Inc.
9600 Main St.
Clarence,  NY  14031
Applicant Contact DON TRAINER
Correspondent
Medisonic U.S.A., Inc.
9600 Main St.
Clarence,  NY  14031
Correspondent Contact DON TRAINER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/07/1990
Decision Date 05/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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