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 K860990
Device Name ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
Applicant
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Applicant Contact LIFTON, MD
Correspondent
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Correspondent Contact LIFTON, MD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/17/1986
Decision Date 05/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-