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, Powered
510(k) Number K041341
Device Name GOLDEN SPYDER, MODEL GS-300
Applicant
GOLDEN TECHNOLOGIES, INC.
401 BRIDGE ST.
OLD FORGE,  PA  18518
Applicant Contact GENE R KULON
Correspondent
GOLDEN TECHNOLOGIES, INC.
401 BRIDGE ST.
OLD FORGE,  PA  18518
Correspondent Contact GENE R KULON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/20/2004
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-