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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K140788
Device Name P-STIM
Applicant
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Classification Product Code
BWK  
Date Received03/31/2014
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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