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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 K101552
Device Name FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
Applicant
Foshan Care Medical Technology Co., Ltd.
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Applicant Contact S.DAVID PIPER, PE
Correspondent
Foshan Care Medical Technology Co., Ltd.
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Correspondent Contact S.DAVID PIPER, PE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/04/2010
Decision Date 03/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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