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FDA 510(k) Application Details - K010782
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K010782
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
TRANSAMERICA MEDICAL SYSTEMS
350 RACE ST.
HOLYOKE, MA 01040 US
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Contact
JOHN F DUNN
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
GZJ
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More FDA Info for this Product Code
Date Received
03/15/2001
Decision Date
04/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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