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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K120920
Device Name HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA
Applicant
HSINER COMPANY
29201 VIA NORTE
TEMECULA,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
HSINER COMPANY
29201 VIA NORTE
TEMECULA,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/27/2012
Decision Date 07/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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