• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name choledochoscope and accessories, flexible/rigid
510(k) Number K082576
Device Name XCHF-T160 VIDEOSCOPE
Original Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley,  PA  18034 0610
Original Contact stacy a kluesner
Regulation Number876.1500
Classification Product Code
FBN  
Date Received09/09/2008
Decision Date 10/21/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-