FDA 510(k) Application Details - K992652

Device Classification Name Interferential Current Therapy

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510(K) Number K992652
Device Name Interferential Current Therapy
Applicant SKYLARK DEVICE & SYSTEMS CO., LTD
34 CHUNG SHAN NORTH RD.,
12TH FL., SEC. 3
TAIPEI TW
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Contact GEORGE K.C. CHEN
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 08/06/1999
Decision Date 02/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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