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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K041406
Device Name NEWPORT C250 AIR COMPRESSOR MODEL C250
Applicant
Newport Medical Instruments
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Applicant Contact RICHARD WATERS
Correspondent
Newport Medical Instruments
760 W 16th St., Bldg. N
Costa Mesa,  CA  92627
Correspondent Contact RICHARD WATERS
Regulation Number868.6250
Classification Product Code
BTI  
Date Received05/26/2004
Decision Date 12/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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