FDA 510(k) Application Details - K131705

Device Classification Name Staple, Implantable

  More FDA Info for this Device
510(K) Number K131705
Device Name Staple, Implantable
Applicant COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven, CT 06473 US
Other 510(k) Applications for this Company
Contact KATHERINE ROBERTSON
Other 510(k) Applications for this Contact
Regulation Number 878.4750

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

  More FDA Info for this Product Code
Date Received 06/11/2013
Decision Date 07/01/2013
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