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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer, medicinal, non-ventilatory (atomizer)
510(k) Number K841469
Device Name MISTY OX DISPOS. NEBULIZER
Applicant
MEDICAL MOLDING CORP. OF AMERICA
1611 Babcock
Newport Beach,  CA  92663
Applicant Contact Terry Bagwell
Correspondent
MEDICAL MOLDING CORP. OF AMERICA
1611 Babcock
Newport Beach,  CA  92663
Correspondent Contact Terry Bagwell
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received04/09/1984
Decision Date 04/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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