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 Neurological Stereotaxic Instrument
510(k) Number K854475
Device Name GHAJAR INTRAVENTRICULAR CATHETER GUIDE
Applicant
Sparta Instrument Corp.
333 W. Wasker Dr. #1900
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
Sparta Instrument Corp.
333 W. Wasker Dr. #1900
Chicago,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/07/1985
Decision Date 02/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-