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510(k) K033452

CWAS 1000 by Fasstech — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2003
Date Received
October 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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