FDA 510(k) Application Details - K013860

Device Classification Name Staple, Implantable

  More FDA Info for this Device
510(K) Number K013860
Device Name Staple, Implantable
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
Other 510(k) Applications for this Company
Contact CHESTER MCCOY
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 11/21/2001
Decision Date 12/19/2001
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