FDA 510(k) Application Details - K954283

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K954283
Device Name Set, Administration, Intravascular
Applicant ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064-3537 US
Other 510(k) Applications for this Company
Contact DAVID T GUZEK
Other 510(k) Applications for this Contact
Regulation Number 880.5440

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

  More FDA Info for this Product Code
Date Received 09/05/1995
Decision Date 05/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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