510(k) K865049

GDC 1824 by Deringer-Ney, Inc. — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1987
Date Received
December 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type