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510(k) K062788

COLLIMATOR, MODEL M-38 by Umi International — Product Code KPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2006
Date Received
September 18, 2006
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

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