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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
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 K964918
Device Name NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
Applicant
CRITICAL DEVICE CORP.
499 nibus st.
brea,  CA  92621
Contact dan hyun
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/09/1996
Decision Date 04/14/1997
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-