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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 K121154
Model NE403
Device Name ULTRASONIC NEBULIZER
Original Applicant
FOSHAN GAUNYING ELECTRONICS CO., LTD.
11820 red hibiscus drive
bonita springs,  FL  34135
Original Contact guenter ginsberg
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/16/2012
Decision Date 08/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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