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510(k) K991399

RADIONICS MICROELECTRODE KIT by Radionics, Inc. — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1999
Date Received
April 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

Other clearances by Radionics, Inc.

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  • K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 4, 2000)
  • K001950 — OPTICAL TRACKING SYSTEM (OTS) (July 26, 2000)
  • K001700 — XPLAN 2.1 (June 28, 2000)
  • K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (May 17, 2000)
  • K000057 — RADIONICS LUMBOPERITONEAL SHUNT (March 20, 2000)
  • K993594 — CONFORMAX MMLC VR1 (December 15, 1999)
  • K992721 — COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE (September 10, 1999)

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