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FDA 510(k) Application Details - K983214
Device Classification Name
Generator, Lesion, Radiofrequency
More FDA Info for this Device
510(K) Number
K983214
Device Name
Generator, Lesion, Radiofrequency
Applicant
RITA MEDICAL SYSTEMS
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW, CA 94043 US
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Contact
DAN BALBIERZ
Other 510(k) Applications for this Contact
Regulation Number
882.4400
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Classification Product Code
GXD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/1998
Decision Date
03/27/2000
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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