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 Wheelchair, Mechanical
510(k) Number K040677
Device Name COMBI SELF PROPELLED SHOWER COMMODE
Applicant
Kjaerulff Rehabilitation A/S
Orkebyvej 6
Otterup,  DK DK-5450
Applicant Contact PHILIP L HARRIS
Correspondent
Kjaerulff Rehabilitation A/S
Orkebyvej 6
Otterup,  DK DK-5450
Correspondent Contact PHILIP L HARRIS
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/15/2004
Decision Date 05/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-