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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 K133009
Device Name NASAL MASK, NASAL MASK, FULL FACE MASK
Applicant
BMC Medical Co., Ltd.
5/F Main Bldg.
#19 Gucheng St. W.,Shijingshan
Beijing,  CN 100043
Applicant Contact MS. JINJING
Correspondent
BMC Medical Co., Ltd.
5/F Main Bldg.
#19 Gucheng St. W.,Shijingshan
Beijing,  CN 100043
Correspondent Contact MS. JINJING
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/25/2013
Decision Date 04/23/2014
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
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