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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K091759
Device Name SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/16/2009
Decision Date 09/18/2009
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
Predetermined Change
Control Plan Authorized		 No
-
-