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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
STE C
CARMICHAEL,  CA  95608
Applicant Contact S.DAVID PIPER, PE
Correspondent
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
4807 EL CAMINO AVE
STE 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
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