FDA 510(k) Application Details - K051197

Device Classification Name Stimulator, Electro-Acupuncture

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510(K) Number K051197
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 CHIANG
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Regulation Number 000.0000

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Classification Product Code BWK
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Date Received 05/10/2005
Decision Date 03/28/2006
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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