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FDA 510(k) Application Details - K020130
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K020130
Device Name
Stimulator, Muscle, Powered
Applicant
ROLOR ELECTRONICS CORP.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact
JEN KE-MIN
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
01/15/2002
Decision Date
12/02/2002
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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