FDA 510(k) Application Details - K041179

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K041179
Device Name Set, Administration, Intravascular
Applicant MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.
930 WANAMAKER
ONTARIO, CA 91761-8151 US
Other 510(k) Applications for this Company
Contact TIM TRUITT
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 05/06/2004
Decision Date 06/04/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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