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 Stent, Ureteral
510(k) Number K072293
Device Name FOSSA URETERAL OPEN STENTS
Applicant
FOSSA MEDICAL, INC.
50 REDFIELD STREET
BOSTON,  MA  02122
Applicant Contact GLORIA KOLB
Correspondent
FOSSA MEDICAL, INC.
50 REDFIELD STREET
BOSTON,  MA  02122
Correspondent Contact GLORIA KOLB
Regulation Number876.4620
Classification Product Code
FAD  
Date Received08/16/2007
Decision Date 08/06/2008
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 Yes
-
-