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FDA 510(k) Application Details - K003369
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K003369
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
LIFECARE LTD.
BEIT HAPA'AMON (BOX 124)
20 HATA'AS ST.,
KFAR SABA 44425 IL
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Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/30/2000
Decision Date
03/08/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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