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510(k) K103410

NEOPAP SYSTEM by Childrens Medical Ventures, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2011
Date Received
November 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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