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510(k) K133528

H&H EMERGENCY CRICOTHYROTOMY KIT by H & H Medical Corporation — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2014
Date Received
November 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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