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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
Device Name ULTRASONIC NEBULIZER
Applicant
FOSHAN GAUNYING ELECTRONICS CO., LTD.
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
FOSHAN GAUNYING ELECTRONICS CO., LTD.
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/16/2012
Decision Date 08/20/2012
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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