FDA 510(k) Application Details - K031375

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K031375
Device Name Stimulator, Muscle, Powered
Applicant BESMED HEALTH BUSINESS CORP.
58 FU-CHIUN ST.
HSIN CHU CITY 300 TW
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Contact DR. JEN KE MIN
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 04/30/2003
Decision Date 11/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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