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 Hearing Aid, Air-Conduction, Prescription
510(k) Number K940667
Device Name STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
Applicant
Starkey Laboratories, Inc.
6700 Washington Ave. S.
Eden Prairie,  MN  55344
Applicant Contact RICK STROMBERG
Correspondent
Starkey Laboratories, Inc.
6700 Washington Ave. S.
Eden Prairie,  MN  55344
Correspondent Contact RICK STROMBERG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/16/1994
Decision Date 08/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-