FDA 510(k) Application Details - K121194

Device Classification Name Clip, Implantable

  More FDA Info for this Device
510(K) Number K121194
Device Name Clip, Implantable
Applicant COVIDIEN
60 MIDDLETOWN AVE.
NORTH HAVEN, CT 06473 US
Other 510(k) Applications for this Company
Contact ANGELA VAN ARSDALE
Other 510(k) Applications for this Contact
Regulation Number 878.4300

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

  More FDA Info for this Product Code
Date Received 04/19/2012
Decision Date 05/03/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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