510(k) K904587

DENSICOMP 250 by L. Keroack Co. — Product Code KPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1991
Date Received
October 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type