510(k) K850197

KELLER CEPHALOMETRIC DEVICE by Gary D. Keller — Product Code IWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type