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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 K082009
Device Name HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
Applicant
Hsiner Co., Ltd.
29201 Via Norte
Temecula,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
Hsiner Co., Ltd.
29201 Via Norte
Temecula,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/23/2008
Decision Date 08/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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