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510(k) K080339

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) by Medsource International, LLC — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2008
Date Received
February 8, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

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  • K081516 — MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT (August 26, 2008)

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