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FDA 510(k) Application Details - K033122
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K033122
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
PRIZM MEDICAL, INC.
5536 TROWBRIDGE DR.
DUNWOODY, GA 30338 US
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Contact
CATHRYN N CAMBRIA
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2003
Decision Date
08/25/2004
Decision
SESU - SE - WITH LIMITATIONS
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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