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FDA 510(k) Application Details - K024279
Device Classification Name
Shoe, Cast
More FDA Info for this Device
510(K) Number
K024279
Device Name
Shoe, Cast
Applicant
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
555 13TH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
890.3025
More FDA Info for this Regulation Number
Classification Product Code
IPG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2002
Decision Date
02/05/2003
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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