FDA 510(k) Applications for Medical Device Product Code "CCQ"
(Nebulizer, Medicinal, Non-Ventilatory (Atomizer))

FDA 510(k) Number Applicant Device Name Decision Date
K964956 AIRPHARMA, LLC E-Z SPACER MASK (SMALL) 04/23/1997
K960593 ARADIGM CORP. SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 05/10/1996
K961455 DIEMOLDING CORP. MEDSHIELD/AEROCHAMBER 07/25/1996
K972397 INTERTEX RESEARCH, INC. EZ SPRAY 09/23/1997
K961894 MDI TUTOR, INC. MDI TUTOR 08/14/1996


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