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FDA 510(k) Application Details - K002336
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K002336
Device Name
Stimulator, Muscle, Powered
Applicant
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN TW
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Contact
DANIEL LEE
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2000
Decision Date
07/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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