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510(k) K180034

Weinmann Tracheostomy Exchange Set by Cook Incorporated — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2018
Date Received
January 4, 2018
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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