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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 K122060
Model TD-7001
Device Name CLEVER TD-7001NEBULIZER
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city,  TW 24888
Original Contact pinjung chen
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/13/2012
Decision Date 03/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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