Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Face Plate Hearing Aid
510(k) Number K974219
Device Name FACEPLATE ASSEMBLY
Applicant
Finetone Hearing Instruments
301 U.S. Rt. 1
Scarborough,  ME  04074
Applicant Contact PAUL MENEZES
Correspondent
Finetone Hearing Instruments
301 U.S. Rt. 1
Scarborough,  ME  04074
Correspondent Contact PAUL MENEZES
Regulation Number874.3300
Classification Product Code
LRB  
Date Received11/10/1997
Decision Date 02/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-