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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 K150263
Device Name K-Pack II Needle-21G x 2
Applicant
TERUMO EUROPE N.V.
INTERLEUVENLAAN 40
LEUVEN,  BE 3001
Applicant Contact M J Aerts
Correspondent
TERUMO EUROPE N.V.
INTERLEUVENLAAN 40
LEUVEN,  BE 3001
Correspondent Contact M J Aerts
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/04/2015
Decision Date 04/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-