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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 K093124
Device Name PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03
Applicant
Cardinal Health 207, Inc.
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact MONTHER ABUSHABAN
Correspondent
Cardinal Health 207, Inc.
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact MONTHER ABUSHABAN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/02/2009
Decision Date 03/10/2010
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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