FDA 510(k) Application Details - K962258

Device Classification Name Stapler, Surgical

  More FDA Info for this Device
510(K) Number K962258
Device Name Stapler, Surgical
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
Other 510(k) Applications for this Company
Contact MELISSA WALKER, M.S., R.A.C.
Other 510(k) Applications for this Contact
Regulation Number 878.4800

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

  More FDA Info for this Product Code
Date Received 06/12/1996
Decision Date 09/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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