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510(k) K083679

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 by Uroval — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2009
Date Received
December 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

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