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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 K140211
Device Name ULTRASONIC MESH NEBULIZER
Applicant
Foshan Gaunying Electronics Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
Foshan Gaunying Electronics Co., Ltd.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/28/2014
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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