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510(k) K140788

P-STIM by Biegler GmbH — Product Code BWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2014
Date Received
March 31, 2014
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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