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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K113549
Device Name COMFORT COUGH
Applicant
SEOIL PACIFIC CORP.
RM # 515-516, ACE HIGH-END
TOWER 235-2 GURO-DONG
SEOUL,  KR 573-901
Applicant Contact Priscilla Chung
Correspondent
SEOIL PACIFIC CORP.
RM # 515-516, ACE HIGH-END
TOWER 235-2 GURO-DONG
SEOUL,  KR 573-901
Correspondent Contact Priscilla Chung
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received12/01/2011
Decision Date 02/21/2013
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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