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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
Other 510(k) Applications for this Contact
Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
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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