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510(k) K171239

TULA Tube Delivery System by Tusker Medical — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2017
Date Received
April 27, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

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