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 Tubing, Fluid Delivery
510(k) Number K131517
Device Name MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
Applicant
MEDRAD, INC. / BAYER MEDICAL CARE, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Applicant Contact LISA A EWING
Correspondent
MEDRAD, INC. / BAYER MEDICAL CARE, INC.
ONE MEDRAD DR.
INDIANOLA,  PA  15051
Correspondent Contact LISA A EWING
Regulation Number880.5440
Classification Product Code
FPK  
Date Received05/28/2013
Decision Date 08/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-