FDA 510(k) Application Details - K013871

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K013871
Device Name Set, Administration, Intravascular
Applicant HORIZON MEDICAL PRODUCTS, INC.
1 HORIZON WAY
MANCHESTER, GA 31816 US
Other 510(k) Applications for this Company
Contact PATRICIA D JONES
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 11/21/2001
Decision Date 03/29/2002
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