• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K112713
Device Name NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
Original Applicant
NORFOLK MEDICAL PRODUCTS, INC.
7350 north ridgeway
skokie,  IL  60076
Original Contact michael dalton
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/28/2011
Decision Date 10/27/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-