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 colonoscope and accessories, flexible/rigid
510(k) Number K090116
Device Name FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
Applicant
FUJINON, INC.
1-324 UETAKE-CHO
KITA- KU SAITAMA,  JP 331-9624
Applicant Contact MASAYUKI OOYATSU
Correspondent
FUJINON, INC.
1-324 UETAKE-CHO
KITA- KU SAITAMA,  JP 331-9624
Correspondent Contact MASAYUKI OOYATSU
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FED  
Date Received01/21/2009
Decision Date 04/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-