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510(k) K001142

AUDIO TECHNOLOGIES S:R.1 by Audio Technologies S.R.L. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2000
Date Received
April 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

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