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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 K063268
Device Name CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
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 Number868.5905
Classification Product Code
BZD  
Date Received10/30/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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