510(k) K963940

EXETER MESH by Howmedica, Inc. — Product Code JDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1997
Date Received
October 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type