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510(k) K061058

NEOZOLINE VENTILATION TUBES by Adept Medical, Ltd. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2006
Date Received
April 17, 2006
Clearance Type
Traditional
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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