SUPER-SIL— 510(k) K940164

Substantially Equivalent

Finetone Hearing Instruments

FDA 510(k) clearance K940164 for SUPER-SIL, Substantially Equivalent on 1994-06-29. Applicant: Finetone Hearing Instruments. Device class: 1.

Clearance details

Applicant: Finetone Hearing Instruments
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1994-01-06
Decision date: 1994-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Portland, ME, US

Download summary PDF View on FDA.gov ↗

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More clearances from Finetone Hearing Instruments

K974219 — FACEPLATE ASSEMBLY1998-02-20
K955692 — FINETONE FSC,1996-02-02
K945780 — FINETONE DISCEET CANAL1994-12-21
K830960 — CUSTOM IN-THE-EAR HEARING AID1983-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.