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FDA 510(k) Application Details - K971542
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K971542
Device Name
Stimulator, Muscle, Powered
Applicant
REHABILICARE, INC.
1811 OLD HIGHWAY 8
NEW BRIGHTON, MN 55112 US
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Contact
GARY L MOORE
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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
04/28/1997
Decision Date
08/14/1997
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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