FDA 510(k) Application Details - K152571

Device Classification Name Stimulator, Electro-Acupuncture

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510(K) Number K152571
Device Name Stimulator, Electro-Acupuncture
Applicant BIEGLER GMBH
ALLHANGSTRASSE 18A
MAUERBACH 3001 AT
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Contact FRIEDRICH NETAUSCHEK
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Regulation Number 000.0000

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Classification Product Code BWK
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Date Received 09/09/2015
Decision Date 05/26/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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