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510(k) K973755

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
October 2, 1997
Clearance Type
Traditional
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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