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510(k) K050123

P-STIM SYSTEM by Neuroscience Therapy Corp. — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2006
Date Received
January 19, 2005
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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