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 K022125
Device Name PROVOX FREEHANDS HME, MODEL 7710
Applicant
ATOS MEDICAL AB
KRAFTGATAN 8
P.O.BOX 183
HORBY,  SE SE-242 22
Applicant Contact EDDY ABERG
Correspondent
ATOS MEDICAL AB
KRAFTGATAN 8
P.O.BOX 183
HORBY,  SE SE-242 22
Correspondent Contact EDDY ABERG
Regulation Number874.3730
Classification Product Code
EWL  
Date Received07/01/2002
Decision Date 07/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-