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 needle, fistula
510(k) Number K001496
Device Name A.V. FISTULA NEEDLE
Applicant
EXELINT INTERNATIONAL CO.
5840 W. CENTINELA AVE.
LOS ANGELES,  CA  90231 -3194
Applicant Contact ARMAND HAMID
Correspondent
EXELINT INTERNATIONAL CO.
5840 W. CENTINELA AVE.
LOS ANGELES,  CA  90231 -3194
Correspondent Contact ARMAND HAMID
Regulation Number876.5540
Classification Product Code
FIE  
Date Received05/15/2000
Decision Date 08/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-