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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 K103410
Device Name NEOPAP SYSTEM
Applicant
CHILDRENS MEDICAL VENTURES LLC
SUITE 200, 3919 WILLIAM
PENN HIGHWAY
MURRYSVILLE,  PA  15668
Applicant Contact SCOTT WRIGHT
Correspondent
CHILDRENS MEDICAL VENTURES LLC
SUITE 200, 3919 WILLIAM
PENN HIGHWAY
MURRYSVILLE,  PA  15668
Correspondent Contact SCOTT WRIGHT
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/22/2010
Decision Date 03/30/2011
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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