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FDA 510(k) Application Details - K013768
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K013768
Device Name
Stimulator, Muscle, Powered
Applicant
THERATECH, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
CAROLANN KOTULA
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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
11/13/2001
Decision Date
07/03/2002
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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