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510(k) K071028

VIEWMATE SYSTEM by Ep Medsystems — Product Code ITN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2007
Date Received
April 11, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Denis Brown
Device Class
Class I
Regulation Number
890.3675
Review Panel
PM
Submission Type

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  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)
  • K032225 — EP-WORKMATE WITH RPM SYSTEM (August 20, 2003)

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