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FDA 510(k) Application Details - K954334
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K954334
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
S.H.P. INTL. PTY., LTD.
2322 DOUGLAS DR.
EUGENE, OR 97405-1711 US
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Contact
ROBERT S MCQUATE
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/1995
Decision Date
01/22/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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