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 Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K181522
Device Name PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received06/11/2018
Decision Date 07/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-