FDA 510(k) Application Details - K020533

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K020533
Device Name Set, Administration, Intravascular
Applicant EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES, CA 90045 US
Other 510(k) Applications for this Company
Contact ARMAND HAMID
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 02/19/2002
Decision Date 12/02/2002
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