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 catheter, retention type, balloon
510(k) Number K062112
Device Name SUNMED FOLEY CATHETERS
Applicant
SUNMED, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
SUNMED, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/24/2006
Decision Date 06/04/2007
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
-
-