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 gastroscope and accessories, flexible/rigid
510(k) Number K093779
Device Name CLEARPATH UGI
Applicant
EASYGLIDE LTD.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
EASYGLIDE LTD.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.1500
Classification Product Code
FDS  
Date Received12/09/2009
Decision Date 03/09/2010
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
-
-