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510(k) K992226

XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM by Radionics, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2000
Date Received
July 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Radionics, Inc.

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  • K001741 — RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (October 23, 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)
  • K991399 — RADIONICS MICROELECTRODE KIT (September 21, 1999)
  • K992721 — COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE (September 10, 1999)

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