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510(k) K990256

CRX WORLD SHUNT by Phoenix Biomedical Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1999
Date Received
January 27, 1999
Clearance Type
Special
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 Phoenix Biomedical Corp.

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  • K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR (October 15, 2003)
  • K024040 — ACCURA ELITE SHUNT SYSTEM (January 27, 2003)
  • K024101 — PHOENIX UNIVERSAL SHUNT SYSTEM (January 27, 2003)
  • K021644 — PERF (OMMAYA STYLE) RESERVOIRS (August 6, 2002)
  • K002476 — LUMBOPERITONEAL SHUNT SYSTEM (November 9, 2000)
  • K000514 — RUMBAR DRAINAGE SYSTEM (May 10, 2000)
  • K991429 — DIAMOND II VALVE (May 19, 1999)
  • K974096 — CRX DIAMOND VALVE (December 8, 1998)
  • K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM (January 14, 1997)

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