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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
Applicant
HEADSTAR MEDICAL PRODUCTS CO., LTD
9 F., NO. 8, SEC. 1,
CHUNG-SHAN ROAD, HSIN-CHANG
CITY, TAIPEI COUNTY,  TW 242
Applicant Contact GLORIA CHEN
Correspondent
HEADSTAR MEDICAL PRODUCTS CO., LTD
9 F., NO. 8, SEC. 1,
CHUNG-SHAN ROAD, HSIN-CHANG
CITY, TAIPEI COUNTY,  TW 242
Correspondent 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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