510(k) K974406

ORTHOPLAN by Ortho-Graphics, Inc. — Product Code HWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1998
Date Received
November 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Template
Device Class
Class I
Regulation Number
888.4800
Review Panel
OR
Submission Type