FDA 510(k) Application Details - K091933

Device Classification Name Stimulator, Electro-Acupuncture

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510(K) Number K091933
Device Name Stimulator, Electro-Acupuncture
Applicant INNO-HEALTH TECHNOLOGY, INC.
8F-2, NO. 61 KUNG-YI ROAD
SECTION 2
TAICHUNG 408 TW
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Contact TERRY C CHANG
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Regulation Number 000.0000

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Classification Product Code BWK
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Date Received 06/30/2009
Decision Date 04/02/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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