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510(k) K090749

ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 by Villa Sistemi Medicali S.P.A. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2009
Date Received
March 20, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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