• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name syringe, piston
510(k) Number K954064
Device Name BECTON DICKINSON SYRINGSE
Original Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
one becton dr.
franklin lakes,  NJ  07417 -1880
Original Contact gregory morgan
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/30/1995
Decision Date 11/21/1995
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
-
-