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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K053466
Device Name HSINER RESUSCITATOR
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 Number868.5915
Classification Product Code
BTM  
Subsequent Product Code
BYE  
Date Received12/13/2005
Decision Date 03/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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