• 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 set, administration, intravascular
510(k) Number K111016
Model FPA
Device Name SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
Original Applicant
ELCAM MEDICAL A.C.A.L.
kibbutz bar-am
d.n. merom hagalil,  IS 13860
Original Contact natasha evronyan
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/12/2011
Decision Date 06/09/2011
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
-
-