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510(k) K864527

DUOCEPH by Gary E. Hall, Dds — Product Code IWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1987
Date Received
November 17, 1986
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

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  • K802140 — LEKSELL STEREOTACTIC SYSTEM (February 5, 1981)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 1978)