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 system, x-ray, tomography, computed
510(k) Number K002258
Device Name ULTRAGUIDE CT-GUIDE 1010
Applicant
ULTRAGUIDE LTD.
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/25/2000
Decision Date 08/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-