510(k) K030632

PD CASTA-H by Mountain Medico, Inc. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2003
Date Received
February 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type