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FDA 510(k) Application Details - K023997
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K023997
Device Name
Stimulator, Muscle, Powered
Applicant
TENSCARE LTD.
76 STOCKPORT ROAD
TIMPERLEY, CHESHIRE WA15 7SN GB
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Contact
BERNARD J TREMAINE
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
12/03/2002
Decision Date
03/03/2003
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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