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510(k) K071424

PMAX NEWTRON XS by Satelec - Acteon Group — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2007
Date Received
May 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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