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510(k) K083780

SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 by Audio Technologies S.R.L. — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2009
Date Received
December 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

Other clearances by Audio Technologies S.R.L.

  • K001142 — AUDIO TECHNOLOGIES S:R.1 (June 23, 2000)

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