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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 K123030
Device Name COMPRESSOR NEBULIZER MODEL MCN-S600XX
Applicant
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Applicant Contact LEON LU
Correspondent
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Correspondent Contact LEON LU
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/28/2012
Decision Date 12/19/2013
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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