510(k) K954915

FLEXIBLE INTRAMEDULLARY REAMER by Zimmer, Inc. — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
October 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type