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 needle, hypodermic, single lumen
510(K) Number K120191
Device Name PUSH-ON NEEDLE 30GX8MM
Applicant
SCANDINAVIAN HEALTH LIMITED
no. 136, kuo sheng
2nd street
taoyuan city, 
Contact sharlin yeh
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/23/2012
Decision Date 05/23/2012
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
-
-