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 stents, drains and dilators for the biliary ducts
510(k) Number K002130
Device Name NIR BILIARY STENT
Applicant
MEDINOL LTD.
KIRYAT ATIDIM, BUILDING 7
ENTRANCE A, 5TH FL., POB 58165
TEL-AVIV,  IL 61581
Applicant Contact NASR SALMAN
Correspondent
MEDINOL LTD.
KIRYAT ATIDIM, BUILDING 7
ENTRANCE A, 5TH FL., POB 58165
TEL-AVIV,  IL 61581
Correspondent Contact NASR SALMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/14/2000
Decision Date 10/30/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
-
-