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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 K070948
Device Name HSINER NEBULIZER BOTTLE
Applicant
Hsiner
29201 Via Norte
Temecula,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
Hsiner
29201 Via Norte
Temecula,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/04/2007
Decision Date 04/25/2007
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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