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 K060007
Device Name BD AUTOSHIELD PEN NEEDLE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact JAMES W HAYNES
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact JAMES W HAYNES
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/03/2006
Decision Date 03/23/2006
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
Recalls CDRH Recalls
-
-