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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K041082
Device Name NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA,  CA  92627
Applicant Contact RICHARD WATERS
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA,  CA  92627
Correspondent Contact RICHARD WATERS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/26/2004
Decision Date 09/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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