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510(k) K091875

E-PULSE by Medevice Corporation — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2009
Date Received
June 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electro-Acupuncture
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

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