FDA 510(k) Application Details - K103562

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K103562
Device Name Set, Administration, Intravascular
Applicant CENTURION MEDICAL PRODUCTS CORPORATION
100 CENTURION WAY
WILLIAMSTON, MI 48895 US
Other 510(k) Applications for this Company
Contact MATTHEW K PRICE
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 12/06/2010
Decision Date 06/23/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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