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510(k) K073702

PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR by Lazarus Medical, LLC — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2008
Date Received
December 31, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Lazarus Medical, LLC

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