• 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 endoscopic injection needle, gastroenterology-urology
510(k) Number K983765
Device Name INJECTION NEEDLE PROBE/DEVICE-TUNIS
Applicant
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
XIMED/PROSURE/INJECTX
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number876.1500
Classification Product Code
FBK  
Date Received10/26/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-