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 Prosthesis, Laryngeal (Taub)
510(k) Number K971244
Device Name PROVOX 2 VOICE PROSTHESIS SYSTEM
Applicant
Atos Medical AB
P.O. Box 183
Horby, Sweden,  SE SE-24222
Applicant Contact EDDY ABERG
Correspondent
Atos Medical AB
P.O. Box 183
Horby, Sweden,  SE SE-24222
Correspondent Contact EDDY ABERG
Regulation Number874.3730
Classification Product Code
EWL  
Date Received04/03/1997
Decision Date 06/06/1997
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
-
-