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, Straight
510(k) Number K150345
Device Name Magic3 Go Intermittent Urinary Catheter
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Applicant Contact WILLIAM HEARD
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Correspondent Contact WILLIAM HEARD
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/11/2015
Decision Date 05/11/2015
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
Recalls CDRH Recalls
-
-