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, Standup
510(k) Number K911608
Device Name GRANSTAND
Applicant
Prime Engineering
4838 W. Jacquelyn, Suite 105
Fresno,  CA  93722
Applicant Contact WILSON BOEGEL
Correspondent
Prime Engineering
4838 W. Jacquelyn, Suite 105
Fresno,  CA  93722
Correspondent Contact WILSON BOEGEL
Regulation Number890.3900
Classification Product Code
IPL  
Date Received04/10/1991
Decision Date 04/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-