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510(k) K974219

Device
FACEPLATE ASSEMBLY
Applicant
FINETONE HEARING INSTRUMENTS
510(k) number
K974219
Product code
LRB  
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-20
Date received
1997-11-10
Regulation
874.3300
Classification name
Face Plate Hearing Aid
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL MENEZES
Address
301 U.S. Rt. 1 Scarborough ME US 04074 04074

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961593INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDSSegi Hearing Aid Co.1996-11-07
K942722MODULE PROGRAMElectone, Inc.1994-09-06
K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)Audina Hearing Instrument1994-06-17
K935048ARTISAN PROGRAMMER & HEARING AIDTelex Communications, Inc.1994-02-09
K933038GOLD AF MODULE, ITEElectone, Inc.1993-08-02
K933046SILVER L MODULE, ITEElectone, Inc.1993-08-02
K933045SILVER RECHARGEABLE MODULE, ITEElectone, Inc.1993-08-02
K933044SILVER LD MODULE, ITEElectone, Inc.1993-08-02
K933043SILVER PPP MODULE, ITEElectone, Inc.1993-08-02
K933040GOLD CD MODULE, ITEElectone, Inc.1993-08-02
K933039GOLD L MODULE, ITEElectone, Inc.1993-08-02
K933037GOLD K AMP, ITEElectone, Inc.1993-08-02
K910901FACEPLATE ITE HEARING AID MODEL 28ATelex Communications, Inc.1991-05-30
K910900FACEPLATE ITE HEARING AID MODEL TCATelex Communications, Inc.1991-05-30
K897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AIDAudina Hearing Instrument1990-03-16

Legacy Summary#

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FDA Review#

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