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510(k) K120079

PRIMED TRACHEOSTOMY TUBES (MULTIPLE) by Primed Halberstadt Medizintechnik GmbH — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
January 10, 2012
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

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