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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K860373
Device Name THE M100 AIR/OXYGEN MIXER
Applicant
Newport Medical Instruments, Inc.
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Applicant Contact DOUG DOMURAT
Correspondent
Newport Medical Instruments, Inc.
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Correspondent Contact DOUG DOMURAT
Regulation Number868.5330
Classification Product Code
BZR  
Date Received02/03/1986
Decision Date 05/21/1986
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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