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 Syringe, Piston
510(k) Number K042934
Device Name 1BD SOLOSHOT IX SYRINGE
Applicant
BECTON DICKINSON & CO.
1 Becton Drive
Franklin Lakes,  NJ  07417
Applicant Contact PETER ZURLO
Correspondent
BECTON DICKINSON & CO.
1 Becton Drive
Franklin Lakes,  NJ  07417
Correspondent Contact PETER ZURLO
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/25/2004
Decision Date 10/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-