FDA 510(k) Application Details - K022892

Device Classification Name Prosthesis, Finger, Constrained, Polymer

  More FDA Info for this Device
510(K) Number K022892
Device Name Prosthesis, Finger, Constrained, Polymer
Applicant ASCENSION ORTHOPEDICS, INC.
8200 CAMERON RD., SUITE C-140
AUSTIN, TX 78754-3832 US
Other 510(k) Applications for this Company
Contact ROBERT M WOLFARTH
Other 510(k) Applications for this Contact
Regulation Number 888.3230

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

  More FDA Info for this Product Code
Date Received 08/30/2002
Decision Date 11/25/2002
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