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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. 510(k)

Active United States

510(k) K083780

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083780 Date23 Mar 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ETA
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 874.3495
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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