FDA 510(k) Application Details - K103833

Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure

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510(K) Number K103833
Device Name Attachment, Breathing, Positive End Expiratory Pressure
Applicant NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND, PA 18974 US
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Contact MONICA FERRANTE
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Regulation Number 868.5965

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Classification Product Code BYE
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Date Received 12/30/2010
Decision Date 04/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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