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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 K984085
Device Name RITEFLO SPACER
Applicant
Aeromax Technologies, Inc.
12020 S. Warner/Elliot Loop
Suite 124
Phoenix,  AZ  85044
Applicant Contact ALLAN M WACHTER
Correspondent
Aeromax Technologies, Inc.
12020 S. Warner/Elliot Loop
Suite 124
Phoenix,  AZ  85044
Correspondent Contact ALLAN M WACHTER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/16/1998
Decision Date 08/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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