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510(k) K113644

PILOT TUBE REPAIR KIT by Instrumentation Industries, Inc. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2012
Date Received
December 12, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

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