FDA 510(k) Application Details - K020669

Device Classification Name Permanent Pacemaker Electrode

  More FDA Info for this Device
510(K) Number K020669
Device Name Permanent Pacemaker Electrode
Applicant Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR, FL 34683 US
Other 510(k) Applications for this Company
Contact MILA DOSKOCIL
Other 510(k) Applications for this Contact
Regulation Number 870.3680

  More FDA Info for this Regulation Number
Classification Product Code DTB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/01/2002
Decision Date 03/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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