FDA 510(k) Application Details - K961578

Device Classification Name Staple, Fixation, Bone

  More FDA Info for this Device
510(K) Number K961578
Device Name Staple, Fixation, Bone
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
Other 510(k) Applications for this Company
Contact JANET G JOHNSON
Other 510(k) Applications for this Contact
Regulation Number 888.3030

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

  More FDA Info for this Product Code
Date Received 04/24/1996
Decision Date 07/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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