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510(k) K920840

OTOVENT by Abigo Medical AB — Product Code MJV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
February 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Inflation, Middle Ear
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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