• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name set, administration, intravascular
510(k) Number K113471
Device Name NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
Original Applicant
NIPRO MEDICAL CORPORATION
3150 n.w. 107th ave.
miami,  FL  33172
Original Contact jessica oswald
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/22/2011
Decision Date 10/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-