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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 K923754
Device Name MISTY OX LAMINAR DIFFUSER HUMIDIFIER
Applicant
MEDICAL MOLDING CORP. OF AMERICA
240 BRIGGS AVE.
COSTA MESA,  CA  92626 -4555
Applicant Contact TERRY BAGWELL
Correspondent
MEDICAL MOLDING CORP. OF AMERICA
240 BRIGGS AVE.
COSTA MESA,  CA  92626 -4555
Correspondent Contact TERRY BAGWELL
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/28/1992
Decision Date 12/07/1992
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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