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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 K053490
Device Name MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
Applicant
Merits Health Products Co., Ltd.
9, Rd. 36
Taichung Industrial Park
Taichung,  TW 407
Applicant Contact STEVE CHAO
Correspondent
Merits Health Products Co., Ltd.
9, Rd. 36
Taichung Industrial Park
Taichung,  TW 407
Correspondent Contact STEVE CHAO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/15/2005
Decision Date 07/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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