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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 K131502
Device Name SEATTLE - PAP
Applicant
SEATTLE CHILDRENS HOSPITAL
1900 NINTH AVENUE
SEATTLE,  WA  98101
Applicant Contact PAUL DRYDEN
Correspondent
SEATTLE CHILDRENS HOSPITAL
1900 NINTH AVENUE
SEATTLE,  WA  98101
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/24/2013
Decision Date 10/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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