FDA 510(k) Application Details - K980987

Device Classification Name Syringe, Piston

  More FDA Info for this Device
510(K) Number K980987
Device Name Syringe, Piston
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES, NJ 07417-1880 US
Other 510(k) Applications for this Company
Contact GREGORY MORGAN
Other 510(k) Applications for this Contact
Regulation Number 880.5860

  More FDA Info for this Regulation Number
Classification Product Code FMF
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/17/1998
Decision Date 06/11/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact