• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K122565
Device Name ARC ENDOCUFF
Original Applicant
BODDINGTONS PLASTICS LTD
unit 6 wheelbarrow park estate
pattenden lane
tonbridge, kent,  GB tn12 9ql
Original Contact john bovis
Regulation Number876.1500
Classification Product Code
FED  
Date Received08/22/2012
Decision Date 09/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-