FDA 510(k) Application Details - K001832

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K001832
Device Name Set, Administration, Intravascular
Applicant MINIMED, INC.
12744 SAN FERNANDO RD.
SYLMAR, CA 91342 US
Other 510(k) Applications for this Company
Contact JENNIFER LYONS
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 06/16/2000
Decision Date 08/18/2000
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