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FDA 510(k) Application Details - K130691
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K130691
Device Name
Stimulator, Muscle, Powered
Applicant
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD
05C.FUHAI KANGLE BUILDING
NASHAN DISTRICT
SHENZHEN 518000 CN
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Contact
FIELD FU
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
03/13/2013
Decision Date
12/20/2013
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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