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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 K121770
Device Name HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
Original Applicant
HEADSTAR MEDICAL PRODUCTS CO., LTD
9 f., no. 8, sec. 1,
chung-shan road, hsin-chang
city, taipei county,  TW 242
Original Contact gloria chen
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/15/2012
Decision Date 04/17/2013
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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