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510(k) K071178

OTOMEDICS SOFT TYMPANOSTOMY TUBE by Otomedics Advanced Medical Technologies, Ltd. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2007
Date Received
April 27, 2007
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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